FDA Pre-Submission Filed โ€” Q261001

Organize your supplement protocol
with clarity

Onset helps you scan bottles, build a time-blocked routine, track intake, and view lab values alongside protocol context. Built for men's health, fertility, performance, recovery, and longevity.

Your supplement routine,
finally organized

Scan your bottles. Build your daily timeline. Track your consistency. Onset is a wellness organizer built for people who take their stack seriously.

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Bottle Scanner

Point your camera at any supplement label. On-device OCR reads the name, dose, and ingredients โ€” added to your routine in seconds.

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Daily Routine Timeline

Organize your supplements into morning, midday, evening, and bedtime blocks. See your full day at a glance and check off each one as you go.

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Consistency Tracking

Build streaks and see completion history so your daily routine is easy to follow and review.

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Supplement Library

General reference information for 150+ supplements sourced from NIH and published dietary guidelines. Know what you're taking.

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Three Modes

Organize your routine around Recovery, Performance, or Fertility. Same supplements, different daily organization. Sex-aware from onboarding.

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Inventory Tracking

Track servings remaining and see low-stock context inside your protocol organizer.

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Lab + Protocol Context

Upload lab values and view supported markers beside current protocol items for organization and tracking. General wellness information only.

A daily organizer
you can actually see

Today's timeline, your protocol library, and starter routines for Recovery, Performance, and Fertility โ€” all in the same place.

Onset Today screen with daily journal, protocol context, step count, and the Midday time block
Today, organized by time block
Onset Protocol library editor with block, goal, and category filters and the routine builder
Organize your protocol library
Onset featured starter protocols for Recovery, Performance, and Fertility with inventory tracking
Featured starters for every mode

Browse all starter protocols โ†’

Lab values beside
your protocol

Onset stores uploaded lab values for personal reference and can show neutral protocol context for supported markers. The app does not diagnose, treat, or tell you what to change.

The Labs surface is designed as a companion to your daily organizer, not a medical interpretation tool. It keeps values, dates, reference ranges, and protocol context in one place.

  • Lab report import and manual value entry
  • Editable draw dates for long-term tracking
  • Supported marker families including hormones, thyroid, metabolic, CBC, lipids, fertility, stress, and nutrients
  • Protocol item context for organization and tracking
  • General wellness disclaimers and user-controlled organization
Onset lab import review screen
Lab import and review
Onset marker detail with linked protocol items and reference range
Marker detail and protocol context
Onset lab insights with adherence, sleep, and mood trends over time
Tracking over time

A wellness organizer today.
A regulated roadmap next.

Onset ships today as a supplement protocol organizer and information tool. Separately, we are pursuing the regulatory pathway for FDA-gated adaptive guidance, and we are being transparent about every step.

We're doing this the right way

On April 2, 2026, we filed a Pre-Submission with the FDA's Center for Devices and Radiological Health. We are seeking formal feedback on the regulatory pathway for adaptive protocol guidance. Those features are separate from the current organizer app and remain disabled until cleared.

The app available today focuses on organization, tracking, and reference information. The FDA pathway is the roadmap for future regulated capabilities, not a claim about current app behavior.

Submission Q261001 ยท CDRH ยท April 2026
Completed

Core App Built

Bottle scanner, daily routine organizer, intake tracking, supplement library, three organization modes, Apple Health integration.

Completed

Lab Organization Layer Built

Lab result import, supported marker families, and neutral lab/protocol classification are active for organization and tracking. No lab interpretation or routine adjustment.

In Progress

FDA Pre-Submission Review

Awaiting FDA feedback on our regulatory pathway. Pre-Sub meeting expected Summer 2026.

Next

Regulatory Submission

Based on FDA guidance, we'll pursue the appropriate clearance pathway to enable personalized protocol features.

The Goal

Adaptive Guidance, Cleared

Future FDA-gated adaptive protocol capabilities enabled only after the appropriate regulatory milestone.

What's live, what's built,
and what's coming

We believe you should know exactly what an app can do today and what it's working toward. Here's our complete status.

Live  Wellness Organizer

  • Bottle scanner with on-device OCR
  • Daily routine timeline with time blocks
  • Intake tracking and completion streaks
  • Supplement reference library (NIH sourced)
  • Recovery / Performance / Fertility modes
  • Personal wellness journal
  • Apple Health data display (read-only)
  • Inventory and low-stock tracking
  • Lab import and lab/protocol organization context
  • Apple Watch, widgets, Live Activities, and App Intents

Regulatory Roadmap  Adaptive Guidance

  • Adaptive protocol changes gated off in production
  • Advisory copy gated off in production
  • Lab interpretation gated off in production
  • Scoring surfaces gated off in production
  • FDA Pre-Submission Q261001 filed
  • Safety documentation and guardrails in progress

Planned  Platform

  • Android app
  • Community protocol sharing
  • Partner mode (share routine with provider)
  • Clinic portal and provider workflow
  • Cross-device account sync

Planned  Safety & Science

  • IEC 62304 software documentation
  • Clinical evidence assembly
  • De Novo or 510(k) submission
  • Blocked substance list (anabolics, SARMs, Rx)
  • Dose caps at NIH Tolerable Upper Intake Levels
  • Prompt injection prevention on AI pipeline

Built for people
who take their protocol seriously

What early Onset users are saying about organizing their routines, labs, and daily tracking.

"I was taking all my supplements at once with no clear view of how they fit together. Now I have them scheduled and organized."
Early Onset user
"Onset has been the missing piece in monitoring my wellness routines. I feel much more confident in what I take and when."
Early Onset user
"Being able to upload lab reports and see them alongside my supplement routine gives me useful daily context."
Early Onset user

Start free.
Unlock Onset Pro when your protocol grows.

Three gates separate Free from Pro: a 10-item routine cap, the bottle scanner, and the intelligence preview. Pick the cadence that fits.

Free

$0

  • Up to 10 protocol items
  • Bottle scanner โ€” locked
  • Intelligence preview โ€” locked
  • Daily timeline + intake tracking
  • Three modes (Recovery, Performance, Fertility)

Onset Pro Most popular

$49/year

  • Unlimited protocol items
  • Bottle scanner unlocked
  • Intelligence preview unlocked
  • Lab + protocol organization views
  • Apple Watch, widgets, Live Activities
  • $7.99/mo also available

Lifetime

$99 once

  • Everything in Onset Pro
  • One payment, no subscription
  • Restore Purchases honored across devices
  • Best for committed protocol builders
  • Available in-app on the Compare plans screen

Building a clinical workflow? Visit Onset Clinic โ†’

Your routine. Your focus.

Same supplements. Different organization. Choose the mode that matches where you are right now.

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Recovery

Organize your routine around rest, restoration, and getting back to baseline. For when your body needs to rebuild.

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Performance

Organize around energy, activity, and showing up. Pre-workout timing, performance day prep, and everything in between.

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Fertility

Organize with cycle awareness and reproductive wellness in mind. Sex-aware from day one, because biology matters.

Follow Onset
on Instagram

Daily protocol notes, label scans, behind-the-scenes from the regulatory work, and the occasional founder tangent.

"I built Onset because I take 15 supplements a day and needed one place to see what I was taking, when, and why."

The supplement industry sells you bottles. Onset gives you a structured place to organize them, track intake, review reference information, and keep lab values beside the protocol you already manage.

The product available today is a wellness organizer. The regulatory roadmap is about future adaptive guidance, and those capabilities stay off until the right clearance path is complete.

โ€” Ryan Curry, Founder ยท Last 1 Enterprises LLC

Start organizing
your protocol today.

Download Onset and build a supplement routine you can see, edit, and track.

Download for iOS

Onset Pro: $7.99/month ยท $49/year ยท $99 lifetime

Onset is a wellness routine organizer. It does not provide medical advice, diagnose diseases, or recommend treatments. Adaptive guidance, lab interpretation, scoring, and routine adjustment features are disabled in the current app while regulatory work continues. Onset has filed a Pre-Submission (Q261001) with the FDA and is pursuing the appropriate regulatory pathway.