Happiest Baby, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Happiest Baby, Inc.”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QTG | Infant Supine Sleep System | 1 | 0 |
Review panels
- General Hospital (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN210039 | De Novo | Infant Supine Sleep System | 2023-03-30 |
Recalls
3 product recalls in 2 recall events; 3 initiated in the last five years. Most recent: 2026-08-07.
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.
Device clinical trials
An industry sponsor named Happiest Baby, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06361303: The Happiest Baby, Inc. SNOO Postmarket Surveillance Study (Recruiting, started 2023-11-29)
Frequently asked questions
How many FDA 510(k) clearances are listed under Happiest Baby, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Happiest Baby, Inc.”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Happiest Baby, Inc.?
The most frequent FDA product codes under this applicant name are QTG (Infant Supine Sleep System, 1).
Next steps
- See all 0 Happiest Baby, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QTG, Happiest Baby, 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.