# Teleflex, Inc.

- Location (FDA's records): Durham, NC
- FDA decisions: 11 (1986–2025): 11 510(k) clearances
- Names in FDA's records: Teleflex, Inc. (10); Teleflex Incorporated (1)
- Product codes: BTT (3), CAZ (3), DYB (3), BSO (1), BTR (1)
- Predicates its devices cite: 14 (1 its own); citations of its devices by later devices: 7 (1 its own)
- Recalls linked to its devices: 22 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Teleflex Medical: 3 (https://510kreport.com/company/teleflex-medical)
- Rusch Intl.: 3 (https://510kreport.com/company/rusch-intl)
- Hudson Respiratory Care, Inc.: 2 (https://510kreport.com/company/hudson-respiratory-care)
- Arrow International, Inc.: 2 (https://510kreport.com/company/arrow-international)
- Arrow Intl., Inc.: 1 (https://510kreport.com/company/arrow-intl)
- Fisher & Paykel Healthcare, Ltd.: 1 (https://510kreport.com/company/fisher-paykel-healthcare)
- Great Batch Medical: 1 (https://510kreport.com/company/great-batch-medical)

## Firms that cite its devices most
- Arrow International, Inc.: 2 (https://510kreport.com/company/arrow-international)
- Teleflexmedical, Inc.: 2 (https://510kreport.com/company/teleflexmedical)
- Medline Industries, Inc.: 1 (https://510kreport.com/company/medline-industries)
- Teleflex Medical: 1 (https://510kreport.com/company/teleflex-medical)

## Its most-cited devices
- K103658: Flextip Plus Closed Tip Epidural Catherter (2012), cited by 4
- K121403: Continuous Peripheral Nerve Block Catheter Kit and Set (2012), cited by 1
- K131912: Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart Column (2014), cited by 1
- K140110: Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/Set (2015), cited by 1

## Recent decisions
- K241451: Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) (Feb 11, 2025)
- K153652: ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set (Jun 21, 2016)
- K140110: Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/Set (Mar 27, 2015)
- K141940: Conchasmart Column (Nov 24, 2014)
- K140556: Conchasmart Breathing Circuit (Sep 24, 2014)
- K131912: Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart Column (Mar 6, 2014)
- K123974: Percutaneous Introducer Kit (Feb 21, 2013)
- K121403: Continuous Peripheral Nerve Block Catheter Kit and Set (Jun 20, 2012)

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