BabySat
Prescription pulse oximeter worn as a sock, for infants who could benefit from additional monitoring at home under a physician's supervision.
owletcare.comAt a glance
- Type
- Device
- Platforms
- Wearable · iOS · Android
- Who it’s for
- Caregivers, clinicians and patients
- Where it’s available
- United States
- Sources cited
- 3
- In the library since
- 24 September 2026
- Regulatory status
- FDA 510(k) K222597, BabySat 3, cleared 16 June 2023, product code DQA; requires a prescription.As recorded from the regulator or the company, with its attribution.
What it does
The company's product page says BabySat requires a prescription and is intended for babies aged 1 to 18 months and weighing 6 to 30 lbs who could benefit from additional monitoring at home, under the supervision of a physician. Readings are shown in the Owlet app.
Independent evidence
Established from a source other than the company.
The FDA cleared BabySat 3 under 510(k) K222597 on 16 June 2023, product code DQA.
In February 2026 the company announced a distribution partnership with PromptCare, a respiratory services and durable medical equipment provider, for BabySat (company release). Pricing is not published on the pages read.
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