510(k) Report

FDA applicant

Owlet Babycare, Inc.

Lehi, UT2 decisions2023–20230 recalls

FDA records 2 decisions for Owlet Babycare, Inc. (Lehi, UT) in 2023: 1 510(k) clearance and 1 De Novo grant. Most are in product codes DQA (Oximeter) and QYU (Infant Pulse Rate And Oxygen Saturation…). Its devices cite 1 predicate, 0 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 Owlet Babycare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2023: 2
2023high 2 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Owlet Babycare, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DQAOximeter1decision
  • QYUInfant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • DEN220091Dream SockOwlet Babycare, Inc. · 20231cites it

What has FDA decided for it lately?

  • DEN220091Dream SockOwlet Babycare, Inc. · 2023
  • K222597BabySat 3Owlet Babycare, Inc. · 2023

All 2 as Owlet Babycare, Inc. →