Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Whittlestone, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070435 | DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# | Whittlestone, Inc. | 2007-07-17 | 152 | 0 |
| K051112 | WHITTLESTONE EXPRESSER | Whittlestone, Inc. | 2005-09-07 | 128 | 0 |
| K002696 | WHITTLESTONE BREASTPUMP | Whittlestone, Inc. | 2001-03-21 | 203 | 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