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Owlet Smart Sock

Owlet Baby Care · Baby Monitor

Staff Reviewed — a person at DeSpy reviewed this rating.

6.8Surveillance
Index
Policy — what its policy permitsD
Evidence — what research provesF

Tracked an infant's blood oxygen saturation, pulse and sleep to alert parents of desaturation, but the FDA found it was an uncleared medical device and forced it off the US market in 2021.

Why this rating

The Owlet Smart Sock was found by the FDA to be an uncleared medical device and forced off the US market in 2021, with a follow-up warning letter in 2024 — a serious and repeated regulatory failure around an infant health-monitoring product.

What it is

Manufacturer
Owlet Baby Care
Category
Baby Monitor
Model years
2013-2021 (relaunched as BabySat)
Market status
Recalled
Companion app
Owlet

The evidence 4

Independent research, regulatory action, lawsuits and journalism about how this device handles personal data — the "what actually happens" axis. Each links to its source.

  1. S5FDA Warning Letter to Owlet Baby Care (2021)
    Regulatory action · U.S. Food and Drug Administration · 2021-10-05

    FDA warning letter forcing Owlet to stop selling its Smart Sock baby monitor in the US for functioning as an uncleared medical device.

    Why it matters here: FDA warning letter directly forced the Owlet Smart Sock off the US market.

  2. S4FDA Warning Letter to Owlet Baby Care (2024)
    Regulatory action · U.S. Food and Drug Administration · 2024-06-05

    A follow-up FDA warning letter to Owlet regarding continued regulatory compliance issues with its infant monitoring products.

    Why it matters here: Follow-up FDA warning letter regarding continued compliance issues.

  3. S4USA Today: FDA Warning — Owlet Baby Monitor Socks
    Journalism · USA Today · 2021-11-30

    Consumer-facing coverage of the FDA's 2021 warning letter that forced Owlet's Smart Sock off the US market.

    Why it matters here: USA Today coverage of the FDA action against Owlet.

  4. S2Fierce Biotech: After FDA Rebuke, Owlet Relaunches Baby Monitoring Sock
    Journalism · Fierce Biotech · 2022-01-01

    Reports that Owlet relaunched a reworked version of its baby monitor (BabySat) after adjusting marketing claims to satisfy FDA requirements.

    Why it matters here: Coverage of Owlet's relaunch after adjusting to satisfy FDA requirements.

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Descriptive, cited, not legal advice; ratings are versioned and corrections create a new version. Data from the IoT Info Grabber DB research project, CC BY-SA 4.0.

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