---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-22-032483"
form_type: "8-K"
ticker: "OWLT"
cik: "0001816708"
company_name: "Owlet, Inc."
filed_at: "2022-12-22T23:59:59+00:00"
generated_at: "2026-06-21T00:11:09.615822+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Owlet's de novo submission for Health Notifications SaMD for heart rate and oxygen

## Summary
- FDA accepted for substantive review Owlet's de novo classification request for over-the-counter SaMD 'Health Notifications'.
- Health Notifications would provide live heart rate and oxygen saturation displays and notifications via Dream Sock.
- This is Owlet's second FDA submission in 2022; first was a 510(k) for a prescription monitor in October.
- CEO Kurt Workman stated FDA authorization could uniquely position Owlet to help caregivers with live health data.
- De novo pathway is for low-to-moderate risk devices with no legally marketed predicate.

## SEC filing metadata
- accession: 0001628280-22-032483
- form_type: 8-K
- ticker: OWLT
- cik: 0001816708
- company_name: Owlet, Inc.
- filed_at: 2022-12-22T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1816708/000162828022032483/0001628280-22-032483-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1816708/000162828022032483/owlt-20221222.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-22-032483
- JSON: https://secwatch.observer/filing/0001628280-22-032483.json
- Plain text: https://secwatch.observer/filing/0001628280-22-032483.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.