Baebies, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Baebies, Inc.” (first 2022, latest 2026), plus 1 De Novo decision, across 3 product codes in 3 review panels. Median 510(k) review time under this name: 252 days. Since 2017 the median was 252 days, against 183 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2022 | 1 | 876 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 2 | 176 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Baebies, Inc. took a median 252 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 183 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 2 | 2 |
| JBF | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening | 1 | 1 |
| PQW | Alpha-D-Galactosidase A (Gla) Newborn Screening Test System | 1 | 0 |
Review panels
- Microbiology (2)
- Clinical Chemistry (1)
- Hematology (1)
Most recent Baebies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261837 | FINDER Flu A&B/SARS-CoV-2 Test | QOF | 2026-09-11 | 101 |
| K252269 | FINDER Flu A&B/SARS-CoV-2 Test | QOF | 2026-03-30 | 252 |
| K201049 | FINDER G6PD | JBF | 2022-09-14 | 876 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN150035 | De Novo | Alpha-D-Galactosidase A (Gla) Newborn Screening Test System | 2017-02-03 |
Recalls
openFDA lists no recalls under a recalling firm named Baebies, 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 Baebies, Inc.?
FDA lists 3 510(k) clearances under the applicant name “Baebies, Inc.” (first 2022, latest 2026), plus 1 De Novo decision, across 3 product codes in 3 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 Baebies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Baebies, Inc. is 252 days. Since 2017: 252 days, versus 183 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Baebies, Inc.?
The most frequent FDA product codes under this applicant name are QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, 2); JBF (Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening, 1); PQW (Alpha-D-Galactosidase A (Gla) Newborn Screening Test System, 1).
Next steps
- See all 3 Baebies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QOF, Baebies, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.