Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Portex, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
163 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033080 | PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESI | Portex, Inc. | 2004-03-10 | 163 | 0 |
| K031057 | PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT | Portex, Inc. | 2003-07-18 | 106 | 7 |
| K023793 | 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR | Portex, Inc. | 2003-02-11 | 90 | 0 |
| K014115 | 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX | Portex, Inc. | 2002-02-27 | 75 | 3 |
| K014073 | HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PR | Portex, Inc. | 2002-02-13 | 65 | 0 |
| K873992 | LARYNGECTOMY TUBE | Portex, Inc. | 1988-03-24 | 175 | 0 |
| K874597 | THERMOVENT 600, 1200, T, 02 | Portex, Inc. | 1988-01-19 | 71 | 3 |
| K862167 | MINI-TRACH KIT | Portex, Inc. | 1986-08-06 | 58 | 0 |
| K842456 | JET VENTILATION ADAPTOR | Portex, Inc. | 1984-07-06 | 14 | 0 |
| K833908 | IRRI-CATH | Portex, Inc. | 1984-02-04 | 82 | 0 |
| K834565 | ENDOBRONCHIAL TWIN LUMEN TUBE | Portex, Inc. | 1984-01-17 | 20 | 0 |
| K840015 | SWIVEL ADAPTOR W/ALARM PORT | Portex, Inc. | 1984-01-17 | 13 | 0 |
| K833189 | HYDROFLOW SUCTION IRRIGATION SYSTEM | Portex, Inc. | 1983-11-28 | 70 | 0 |
| K830716 | CARDIO-ESOPHASCOPE | Portex, Inc. | 1983-08-12 | 157 | 0 |
| K830352 | REINFORCED SILICONE TRACHEAL TUBE | Portex, Inc. | 1983-03-08 | 33 | 0 |
| K810147 | ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE | Portex, Inc. | 1981-02-05 | 15 | 0 |
| K802065 | CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG | Portex, Inc. | 1980-09-09 | 13 | 0 |
| K792202 | TROCAR CATHETER/THORACIC CATHETER | Portex, Inc. | 1979-11-20 | 18 | 0 |
| K781052 | CONTINUOUS EPIDURAL ANESTHESIA TRAY | Portex, Inc. | 1978-08-02 | 41 | 0 |
| K770112 | SPECIMEN COLLECTOR | Portex, Inc. | 1977-03-14 | 54 | 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