Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sims Portex , Ltd. — 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) |
|---|---|---|---|---|---|
| K012277 | PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POL | Sims Portex , Ltd. | 2002-02-11 | 207 | 0 |
| K012068 | WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL | Sims Portex , Ltd. | 2001-08-03 | 32 | 1 |
| K001555 | SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 | Sims Portex , Ltd. | 2000-08-02 | 76 | 0 |
| K000628 | WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE O | Sims Portex , Ltd. | 2000-03-13 | 18 | 1 |
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