# Thomas Medical Products, Inc.

- Location (FDA's records): Malvern, PA
- FDA decisions: 23 (1990–2013): 23 510(k) clearances
- Product codes: DYB (17), DQY (3), DTL (1), DRC (1), LIT (1)
- Predicates its devices cite: 13 (6 its own); citations of its devices by later devices: 29 (6 its own)
- Recalls linked to its devices: 17 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Merit Medical Systems, Inc.: 2 (https://510kreport.com/company/merit-medical-systems)
- Guidant Corp.: 2 (https://510kreport.com/company/guidant)
- Biotronik, Inc.: 1 (https://510kreport.com/company/biotronik)
- Arrow Intl., Inc.: 1 (https://510kreport.com/company/arrow-intl)
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)

## Firms that cite its devices most
- Merit Medical Systems, Inc.: 5 (https://510kreport.com/company/merit-medical-systems)
- Oscor, Inc.: 3 (https://510kreport.com/company/oscor)
- Medtronic Vascular: 3 (https://510kreport.com/company/medtronic-vascular)
- Acumen Medical, Inc.: 2 (https://510kreport.com/company/acumen-medical)
- Hansen Medical, Inc.: 2 (https://510kreport.com/company/hansen-medical)
- Cardio-Optics, Inc.: 1 (https://510kreport.com/company/cardio-optics)
- Great Batch Medical: 1 (https://510kreport.com/company/great-batch-medical)
- St Jude Medical: 1 (https://510kreport.com/company/st-jude-medical)

## Its most-cited devices
- K003731: Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve (2001), cited by 9
- K011727: Transseptal Needle/Trocar (2002), cited by 4
- K081341: Reinforced Catheter Introducer System (Rcis) (2008), cited by 3
- K934901: Tear-Away Sheath Introducer Set with Integral Hemostasis Valve (1994), cited by 3
- K120158: Coronary Sinus Guide and Lateral Vein Introducer Kits (2012), cited by 2
- K004026: Braided Guiding Introducer (2001), cited by 2

## Recent decisions
- K122431: Heartspan Steerable Introducer Kit (Jan 29, 2013)
- K120158: Coronary Sinus Guide and Lateral Vein Introducer Kits (Aug 14, 2012)
- K101015: Guide Catheters and Accessories (Sep 23, 2010)
- K083269: Crossover (Feb 3, 2009)
- K081341: Reinforced Catheter Introducer System (Rcis) (May 14, 2008)
- K072745: Y-Glide (Jan 4, 2008)
- K043438: Large Bore Splittable Introducer Kit (Feb 15, 2005)
- K040713: Modification to Braided Guiding Introducer System (Jun 1, 2004)

Source page: https://510kreport.com/company/thomas-medical-products