Gerber Products Co.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Gerber Products Co.” (first 1983, latest 2004), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 110 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HGX | Pump, Breast, Powered | 3 | 3 |
| HGY | Pump, Breast, Non-Powered | 2 | 2 |
Review panels
Most recent Gerber Products Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K043098 | GERBER DOUBLE ELECTRIC BREAST PUMP | HGX | 2004-12-15 | 36 |
| K942534 | GERBER NATURAL COMFORT BATTERY BREAST PUMP | HGX | 1995-05-25 | 363 |
| K902552 | GERBER PRECIOUS CARE ELECTRIC BREAST PUMP | HGY | 1990-09-26 | 110 |
| K891996 | GERBER PRECIOUS CARE ELECTRIC BREAST PUMP | HGX | 1989-08-07 | 132 |
| K832597 | GERBER PRECISION CARE BREAST PUMP | HGY | 1983-09-12 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Gerber Products Co..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Gerber Chair Mates, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Gerber Products Co.?
FDA lists 5 510(k) clearances under the applicant name “Gerber Products Co.” (first 1983, latest 2004), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Gerber Products Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gerber Products Co. is 110 days.
Which FDA product codes appear under Gerber Products Co.?
The most frequent FDA product codes under this applicant name are HGX (Pump, Breast, Powered, 3); HGY (Pump, Breast, Non-Powered, 2).
Next steps
- See all 5 Gerber Products Co. clearances with predicates and recalls
- Run predicate analysis for product code HGX, Gerber Products Co.'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.