# Concord/Portex

- Location (FDA's records): Keene, NH
- FDA decisions: 23 (1989–1993): 23 510(k) clearances
- Product codes: BTO (3), FMI (3), JKA (3), BSY (3), CBT (2), CAI (1), EIA (1), BYD (1), MAJ (1), BYO (1), BSJ (1), CAF (1)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 24 (1 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Portex, Inc.: 5 (https://510kreport.com/company/portex)
- Smiths Medical Asd, Inc.: 3 (https://510kreport.com/company/smiths-medical-asd)
- Tracoe Medical GmbH: 2 (https://510kreport.com/company/tracoe-medical)
- Ovus Systems: 2 (https://510kreport.com/company/ovus-systems)
- Smiths Industries Medical Systems, Inc.: 2 (https://510kreport.com/company/smiths-industries-medical-systems)
- Hudson Respiratory Care, Inc.: 2 (https://510kreport.com/company/hudson-respiratory-care)
- Sims Portex, Inc.: 1 (https://510kreport.com/company/sims-portex)
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)

## Its most-cited devices
- K912124: Tracheostomy Tube and Cuff (1991), cited by 5
- K903730: D.I.C. Tracheostomy Tubes & Laryngectomy Tubes (1990), cited by 4
- K923127: Needle-Pro Cartridge (1993), cited by 3
- K911037: Safety Needle Sheath, Modification (1991), cited by 3
- K904198: Safety Needle Sheath (1990), cited by 2
- K902383: Steri-Cath (TM) (1990), cited by 2

## Recent decisions
- K923559: Steri-Cath Mdi (Oct 25, 1993)
- K930218: Subcutaneous Tunneling Needle and Handles (Jul 27, 1993)
- K924541: Epidural Minipack (Jul 9, 1993)
- K930286: Dri-Vendt/Provent/Accuvent Arterial Blood Gas Kits (Jun 22, 1993)
- K923127: Needle-Pro Cartridge (Apr 29, 1993)
- K923910: Heat Moisture Condenser (Jan 26, 1993)
- K922749: Low Profile Tracheostomy Tube (Sep 2, 1992)
- K922445: Vacu-Pro (Aug 12, 1992)

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