Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gerber Products Co. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
110 daysmedian FDA review time
363 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K043098 | GERBER DOUBLE ELECTRIC BREAST PUMP | Gerber Products Co. | 2004-12-15 | 36 | 0 |
| K942534 | GERBER NATURAL COMFORT BATTERY BREAST PUMP | Gerber Products Co. | 1995-05-25 | 363 | 0 |
| K902552 | GERBER PRECIOUS CARE ELECTRIC BREAST PUMP | Gerber Products Co. | 1990-09-26 | 110 | 0 |
| K891996 | GERBER PRECIOUS CARE ELECTRIC BREAST PUMP | Gerber Products Co. | 1989-08-07 | 132 | 0 |
| K832597 | GERBER PRECISION CARE BREAST PUMP | Gerber Products Co. | 1983-09-12 | 41 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda