Owlet Smart Sock
Owlet Baby Care · Baby Monitor
✓ Reviewed
Index
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
- Requires a cloud account
- Works offline
- 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, breaches and journalism about this device — the "what actually happens" axis. Each links to its source.
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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.
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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.
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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.
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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.
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.