# Rex Medical

- Location (FDA's records): Great Neck, NY
- FDA decisions: 22 (2003–2021): 21 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Rex Medical (13); Rex Medical, L.P. (9)
- Product codes: MCW (8), DYB (4), MSD (3), DTK (3), MGB (1), PNO (1), QEW (1), BTA (1)
- 510(k) review time since 2016: median 107 days, against 119 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 50 (23 its own); citations of its devices by later devices: 31 (23 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 6 (https://510kreport.com/company/boston-scientific)
- Arrow Intl., Inc.: 5 (https://510kreport.com/company/arrow-intl)
- Bacchus Vascular, Inc.: 2 (https://510kreport.com/company/bacchus-vascular)
- Cordis Corp.: 2 (https://510kreport.com/company/cordis)
- C.R. Bard, Inc.: 2 (https://510kreport.com/company/cr-bard)
- Terumo Medical Corp.: 2 (https://510kreport.com/company/terumo-medical)
- Clincal Instruments Corp.: 1 (https://510kreport.com/company/clincal-instruments)
- Elcam Medical Acal: 1 (https://510kreport.com/company/elcam-medical-acal)

## Firms that cite its devices most
- Argon Medical Devices, Inc.: 3 (https://510kreport.com/company/argon-medical-devices)
- Transit Scientific, LLC: 1 (https://510kreport.com/company/transit-scientific)
- Venturemed Group: 1 (https://510kreport.com/company/venturemed-group)
- Phase One Medical: 1 (https://510kreport.com/company/phase-one-medical)
- Vetex Medical, Ltd.: 1 (https://510kreport.com/company/vetex-medical)
- Crux Biomedical: 1 (https://510kreport.com/company/crux-biomedical)

## Its most-cited devices
- K022170: Inner-Lock Locking Introducer Sheaths (2003), cited by 4
- K031610: Rex Medical Cleaner Rotational Thrombectomy System (2003), cited by 3
- K032569: Short Introducer Sheath (2003), cited by 3
- K113103: Splitwire Percutaneous Transluminal Angioplasty Scoring Device (2012), cited by 2
- K060904: Cleaner Rotational Thrombectomy System (2006), cited by 2
- K141617: Cleaner Rotational Thrombectomy System (2014), cited by 2

## Recent decisions
- K212351: Revolution Peripheral Atherectomy System (Dec 15, 2021)
- K191419: Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire (Sep 12, 2019)
- K173389: Rex Medical Aspiration Pump (Jan 30, 2018)
- P150022: Closer Vascular Sealing System (Feb 12, 2016)
- K143405: Option (TM) ELITE Vena Cava Filter 100cm System (Apr 16, 2015)
- K141617: Cleaner Rotational Thrombectomy System (Nov 14, 2014)
- K133243: Option Elite Vena Cava Filter System (Dec 17, 2013)
- K120346: Cleaner Rotational Thrombectomy System (Jun 1, 2012)

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