# Teleflexmedical, Inc.

- Location (FDA's records): Durham, NC
- FDA decisions: 64 (1985–2024): 64 510(k) clearances
- Product codes: GCJ (5), BTR (5), EZL (4), GAT (4), CAF (4), DYB (4), CBN (3), CAC (3), DQX (3), MSD (3), GEI (2), CCK (2)
- 510(k) review time since 2016: median 213 days, against 163 for FDA's reviews in the same codes and years (4 of 12 faster)
- Predicates its devices cite: 86 (15 its own); citations of its devices by later devices: 62 (15 its own)
- Recalls linked to its devices: 51 (22 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Teleflex Medical: 8 (https://510kreport.com/company/teleflex-medical)
- Rusch Intl.: 8 (https://510kreport.com/company/rusch-intl)
- Taut, Inc.: 4 (https://510kreport.com/company/taut)
- Mini Lap Technologies, Inc.: 4 (https://510kreport.com/company/mini-lap-technologies)
- Hudson Respiratory Care, Inc.: 3 (https://510kreport.com/company/hudson-respiratory-care)
- Sheridan Catheter Corp.: 3 (https://510kreport.com/company/sheridan-catheter)
- Advanced Warming Systems, Inc.: 2 (https://510kreport.com/company/advanced-warming-systems)
- Teleflex, Inc.: 2 (https://510kreport.com/company/teleflex)

## Firms that cite its devices most
- Teleflex Medical: 13 (https://510kreport.com/company/teleflex-medical)
- Tfx Medical, Inc.: 4 (https://510kreport.com/company/tfx-medical)
- Cayenne Medical, Inc.: 4 (https://510kreport.com/company/cayenne-medical)
- Tianjin Medis Medical Device Co., Ltd.: 3 (https://510kreport.com/company/tianjin-medis-medical-device)
- Tfx Medical Group: 3 (https://510kreport.com/company/tfx-medical-group)
- Arrow International, Inc.: 3 (https://510kreport.com/company/arrow-international)
- Teleflex Medical Sdn. Bhd.: 2 (https://510kreport.com/company/teleflex-medical-sdn-bhd)
- Cardiovascular Dynamics, Inc.: 2 (https://510kreport.com/company/cardiovascular-dynamics)

## Its most-cited devices
- K070673: Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture (2007), cited by 7
- K150438: Force Fiber OrthoTape suture (2015), cited by 4
- K851140: Teleflex Medical Introducer Needle (1985), cited by 4
- K132362: Weck Efx Endo Fascial Closure System (2013), cited by 4
- K153076: silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL (2016), cited by 3
- K920908: Over the Needle Splitable Catheter Assembly Type 1 (1992), cited by 3

## Recent decisions
- K232469: Rüsch Latex Gold Foley Catheter (Aug 1, 2024)
- K212077: Teleflex Rusch SoftSimplastic Foley Catheters (Jul 27, 2023)
- K192324: Sheridan Spiral-Flex Endotracheal Tubes (Dec 6, 2019)
- K182847: Hudson RCI Voldyne Volumetric Exerciser (Jul 1, 2019)
- K181979: Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter (May 24, 2019)
- K183461: Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter (May 8, 2019)
- K181852: Percuvance Percutaneous Surgical System (Oct 12, 2018)
- K173280: Neonatal ConchaSmart Breathing Circuits (Aug 2, 2018)

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