# Portex, Inc.

- Location (FDA's records): Mchenry, IL
- FDA decisions: 27 (1977–2004): 27 510(k) clearances
- Names in FDA's records: Portex, Inc. (20); Portex , Ltd. (7)
- Product codes: BTO (3), BTM (2), BTR (2), CAZ (2), BZT (2), JOH (2), DWF (1), CAH (1), BYD (1), GCJ (1), MQE (1), BSY (1)
- Predicates its devices cite: 30 (1 its own); citations of its devices by later devices: 25 (1 its own)
- Recalls linked to its devices: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sims Portex, Inc.: 6 (https://510kreport.com/company/sims-portex)
- Concord/Portex: 5 (https://510kreport.com/company/concord-portex)
- Smiths Industries Medical Systems, Inc.: 4 (https://510kreport.com/company/smiths-industries-medical-systems)
- Shiley, Inc.: 2 (https://510kreport.com/company/shiley)
- Cook Ob/Gyn: 2 (https://510kreport.com/company/cook-ob-gyn)
- CooperSurgical, Inc.: 2 (https://510kreport.com/company/coopersurgical)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)
- Mentor Medical Limited: 1 (https://510kreport.com/company/mentor-medical)

## Firms that cite its devices most
- Smiths Medical: 4 (https://510kreport.com/company/smiths-medical)
- Smiths Medical Asd, Inc.: 4 (https://510kreport.com/company/smiths-medical-asd)
- Crossbay Medical, Inc.: 1 (https://510kreport.com/company/crossbay-medical)
- Hangzhou Bever Medical Devices Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-bever-medical-devices)
- PAJUNK GmbH Medizintechnologie: 1 (https://510kreport.com/company/pajunk-medizintechnologie)
- Atrion Medical Products, Inc.: 1 (https://510kreport.com/company/atrion-medical-products)
- Kitazato Corporation: 1 (https://510kreport.com/company/kitazato)
- Origio A/S: 1 (https://510kreport.com/company/origio-a-s)

## Its most-cited devices
- K030381: Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula (2003), cited by 4
- K032112: P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) (2004), cited by 4
- K830352: Reinforced Silicone Tracheal Tube (1983), cited by 3
- K030570: Blue Line Ultra Suctionaid Tracheostomy Tube (2003), cited by 3
- K033084: Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter (2003), cited by 3
- K033080: Portex 24G Pediatric Epidural and Peripheral Block Anesthesia Catheter (2004), cited by 2

## Recent decisions
- K033080: Portex 24G Pediatric Epidural and Peripheral Block Anesthesia Catheter (Mar 10, 2004)
- K040014: Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers for Sizes 7, 8 and 9MM Tubes Only (Feb 13, 2004)
- K032112: P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) (Jan 26, 2004)
- K033084: Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter (Dec 19, 2003)
- K032716: Portex Thermovent Hepa Hme Breathing Filter with CO2 Port (Sterile and Non-Sterile) (Nov 28, 2003)
- K030570: Blue Line Ultra Suctionaid Tracheostomy Tube (Sep 17, 2003)
- K030381: Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula (Aug 27, 2003)
- K031057: Per-Fit Percutaneous Dilational Tracheostomy Kit (Jul 18, 2003)

Source page: https://510kreport.com/company/portex