510(k) Report

FDA applicant

Verily Life Sciences, LLC

South San Francisco, CA4 decisions2019–20240 recalls

FDA records 4 decisions for Verily Life Sciences, LLC (South San Francisco, CA) from 2019 to 2024: 4 510(k) clearances. Most are in product codes DXH (Transmitters And Receivers…) and HKI (Camera, Ophthalmic, Ac-Powered). Since 2016 its 510(k)s took a median of 134 days from receipt to decision, against 146 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Verily Life Sciences, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2019: 12020: 12022: 12024: 1
2019high 1 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Verily Life Sciences, LLC by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Verily Life Sciences, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DXHTransmitters And Receivers, Electrocardiograph, Telephone3decisions
  • HKICamera, Ophthalmic, Ac-Powered1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 134 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 146 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K192415Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC · 20202cite it
  • K182456Study WatchVerily Life Sciences, LLC · 20191cites it

What has FDA decided for it lately?

  • K242508Verily Numetric Retinal CameraVerily Life Sciences, LLC · 2024
  • K213357Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC · 2022
  • K192415Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC · 2020
  • K182456Study WatchVerily Life Sciences, LLC · 2019

All 4 as Verily Life Sciences, LLC →