---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-23-038331"
form_type: "8-K"
ticker: "OWLT"
cik: "0001816708"
company_name: "Owlet, Inc."
filed_at: "2023-11-09T23:59:59+00:00"
generated_at: "2026-06-08T07:25:38.977240+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Owlet receives FDA de novo clearance for Dream Sock as first OTC infant pulse oximeter

## Summary
- FDA-cleared Dream Sock monitors pulse rate and oxygen saturation for healthy infants 1-18 months, 6-30 lbs.
- Device provides Health Notifications with lights and alarms when readings fall outside preset ranges.
- Medical-grade features to roll out to existing and new Dream Sock users by end of 2023 (U.S. only).
- Follows prior FDA clearance of prescription BabySat system; Dream Sock now available without prescription.
- CEO calls it a 'significant breakthrough' in at-home infant care and commitment to innovation.

## SEC filing metadata
- accession: 0001628280-23-038331
- form_type: 8-K
- ticker: OWLT
- cik: 0001816708
- company_name: Owlet, Inc.
- filed_at: 2023-11-09T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1816708/000162828023038331/0001628280-23-038331-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1816708/000162828023038331/owlt-20231109.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-23-038331
- JSON: https://secwatch.observer/filing/0001628280-23-038331.json
- Plain text: https://secwatch.observer/filing/0001628280-23-038331.txt

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