Owlet's Dream Sock becomes a predicate as FDA codifies three De Novos

MedDevice Startups Staff · Oct 9 · 3 min read · Via Federal Register, 21 CFR 870.2705

FDA turned three 2023 De Novo grants into Class II regulations effective October 9. The over-the-counter infant pulse rate and oxygen saturation monitor goes to 21 CFR 870.2705, from Owlet Baby Care's Dream Sock (DEN220091, granted November 8, 2023). The docket is FDA-2026-N-10993.

The other two are in vitro diagnostics. A nucleic acid detection system for non-viral sexually transmitted infection organisms using home-collected specimens goes to 21 CFR 866.3385. It came from the Simple 2 Test, requested by LetsGetChecked (then PrivaPath Diagnostics) in November 2020 and granted November 15, 2023. A hematopoietic cell enrichment kit goes to 21 CFR 866.6120, from STEMCELL Technologies Canada's EasySep Human Bone Marrow CD138 Positive Selection Kit, granted November 6, 2023. All three types still require a 510(k), since FDA has not exempted them under section 510(m).

The special controls are the part worth reading. For 870.2705 they call for clinical performance testing that treats skin pigmentation as a confounder, non-clinical evidence that the device detects adequate photoplethysmography signal quality, alarm validation, and human factors data showing a caregiver can interpret the output and the next step from the labeling alone. A follow-on 510(k) gets measured against that text, so pull the regulation instead of reverse-engineering the De Novo decision summary.

Questions & Answers

Which device type did FDA classify under 21 CFR 870.2705?

21 CFR 870.2705 is the Class II regulation for an infant pulse rate and oxygen saturation monitor intended for over-the-counter use. FDA created it effective October 9, 2026, from the Owlet Baby Care Dream Sock De Novo (DEN220091), granted November 8, 2023.

Do the devices in FDA's new October 2026 classifications still need a 510(k)?

Yes. FDA has not exempted 21 CFR 870.2705, 21 CFR 866.3385 or 21 CFR 866.6120 under section 510(m), so devices of these types still require premarket notification.

Which De Novo devices did FDA codify on October 9, 2026?

FDA codified the Owlet Baby Care Dream Sock infant pulse oximeter at 21 CFR 870.2705, the LetsGetChecked Simple 2 Test for home-collected sexually transmitted infection specimens at 21 CFR 866.3385, and the STEMCELL Technologies EasySep Human Bone Marrow CD138 Positive Selection Kit at 21 CFR 866.6120.

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