Owlet Babycare, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Owlet Babycare, Inc.” (first 2023, latest 2023), plus 1 De Novo decision, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 291 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 1 | 291 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Owlet Babycare, Inc. took a median 291 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 210 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQA | Oximeter | 1 | 1 |
| QYU | Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use | 1 | 0 |
Review panels
- Anesthesiology (1)
- Cardiovascular (1)
Most recent Owlet Babycare, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222597 | BabySat 3 | DQA | 2023-06-16 | 291 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220091 | De Novo | Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use | 2023-11-08 |
Recalls
openFDA lists no recalls under a recalling firm named Owlet Babycare, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Owlet Babycare, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Owlet Babycare, Inc.” (first 2023, latest 2023), plus 1 De Novo decision, across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Owlet Babycare, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Owlet Babycare, Inc. is 291 days.
Which FDA product codes appear under Owlet Babycare, Inc.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 1); QYU (Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use, 1).
Next steps
- See all 1 Owlet Babycare, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Owlet Babycare, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.