Portex, Inc.: FDA clearances and approvals
Portex, Inc. has 27 FDA 510(k) clearances (first 1977, latest 2004), across 20 product codes in 6 review panels. Median 510(k) review time: 70 days. openFDA lists 12 product recalls by a recalling firm named Portex, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTO | Tube, Tracheostomy (W/Wo Connector) | 3 | 3 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 2 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 2 | 2 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 2 | 2 |
| CAZ | Anesthesia Conduction Kit | 2 | 2 |
| JOH | Tube Tracheostomy And Tube Cuff | 2 | 2 |
| BSO | Catheter, Conduction, Anesthetic | 1 | 1 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| BTS | Tube, Bronchial (W/Wo Connector) | 1 | 1 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 | 1 |
Plus 10 more product codes.
Review panels
- Anesthesiology (18)
- General Hospital (3)
- Obstetrics and Gynecology (2)
- Cardiovascular (1)
- Ear, Nose and Throat (1)
- General and Plastic Surgery (1)
Most recent Portex, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033080 | PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER | CAZ | 2004-03-10 | 163 |
| K040014 | PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY | JOH | 2004-02-13 | 51 |
| K032112 | P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) | BTR | 2004-01-26 | 201 |
| K033084 | WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER | MQF | 2003-12-19 | 81 |
| K032716 | PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE) | CAH | 2003-11-28 | 87 |
| K030570 | BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE | BTO | 2003-09-17 | 205 |
| K030381 | PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA | BTO | 2003-08-27 | 203 |
| K031057 | PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT | JOH | 2003-07-18 | 106 |
| K031622 | WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS | MQE | 2003-06-26 | 34 |
| K023793 | 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR | BTM | 2003-02-11 | 90 |
17 earlier clearances. See the full list in Caduvo.
Recalls
12 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2003-10-10.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Portex, Inc. have?
Portex, Inc. has 27 FDA 510(k) clearances (first 1977, latest 2004), across 20 product codes in 6 review panels.
How long does FDA take to clear Portex, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Portex, Inc.'s cleared 510(k)s is 70 days.
What devices does Portex, Inc. make?
Its most frequent FDA product codes are BTO (Tube, Tracheostomy (W/Wo Connector), 3); BTM (Ventilator, Emergency, Manual (Resuscitator), 2); BTR (Tube, Tracheal (W/Wo Connector), 2).
Has Portex, Inc. had device recalls?
openFDA lists 12 product recalls in 4 recall events by a recalling firm whose name matches Portex, Inc; the most recent began 2003-10-10. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 27 Portex, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTO, Portex, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.