Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Portex , Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
205 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040014 | PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DIL | Portex , Ltd. | 2004-02-13 | 51 | 0 |
| K032112 | P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) | Portex , Ltd. | 2004-01-26 | 201 | 0 |
| K033084 | WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TR | Portex , Ltd. | 2003-12-19 | 81 | 6 |
| K032716 | PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (S | Portex , Ltd. | 2003-11-28 | 87 | 0 |
| K030570 | BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE | Portex , Ltd. | 2003-09-17 | 205 | 0 |
| K030381 | PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSA | Portex , Ltd. | 2003-08-27 | 203 | 1 |
| K031622 | WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS | Portex , Ltd. | 2003-06-26 | 34 | 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