Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Limerick, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132220 | PJ'S SERENITY | Limerick, Inc. | 2015-02-20 | 583 | 0 |
| K051926 | LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP | Limerick, Inc. | 2005-12-12 | 147 | 0 |
| K021739 | LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002 | Limerick, Inc. | 2003-01-10 | 227 | 0 |
| K012275 | PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP | Limerick, Inc. | 2002-01-07 | 172 | 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