510(k) Report

FDA applicant

Rex Medical

Great Neck, NY22 decisions2003–20216 recalls

FDA records 22 decisions for Rex Medical (Great Neck, NY) from 2003 to 2021: 21 510(k) clearances and 1 original PMA approval. Most are in product codes MCW (Catheter, Peripheral, Atherectomy) and DYB (Introducer, Catheter). Since 2016 its 510(k)s took a median of 107 days from receipt to decision, against 119 for FDA’s reviews in the same codes and years. Its devices cite 50 predicates, 23 of them its own earlier devices. 6 recalls are linked to its devices.

FDA’s records also spell it “Rex Medical, L.P.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Rex Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 12009: 12010: 22012: 22013: 12014: 12015: 12016: 12018: 12019: 12021: 1
2007high 2 (2010) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2025

2014: 32023: 12025: 1
2007high 3 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Rex Medical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MCWCatheter, Peripheral, Atherectomy8decisions
  • DYBIntroducer, Catheter4decisions
  • MSDCatheter, Hemodialysis, Implanted3decisions
  • DTKFilter, Intravascular, Cardiovascular3decisions
  • MGBDevice, Hemostasis, Vascular1decision
  • PNOCatheter, Percutaneous, Cutting/Scoring1decision

Also: QEW (1), BTA (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 107 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 119 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 50 predicates; 23 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 31 times; 23 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K022170Inner-Lock Locking Introducer SheathsRex Medical · 20034cite it
  • K031610Rex Medical Cleaner Rotational Thrombectomy SystemRex Medical · 20033cite it
  • K032569Short Introducer SheathRex Medical · 20033cite it
  • K113103Splitwire Percutaneous Transluminal Angioplasty Scoring DeviceRex Medical · 20122cite it
  • K060904Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 20062cite it
  • K141617Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 20142cite it

What has FDA decided for it lately?

  • K212351Revolution Peripheral Atherectomy SystemRex Medical, L.P. · 2021
  • K191419Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy GuidewireRex Medical, L.P. · 2019
  • K173389Rex Medical Aspiration PumpRex Medical, L.P. · 2018
  • P150022Closer Vascular Sealing SystemRex Medical, L.P. · 2016
  • K143405Option (TM) ELITE Vena Cava Filter 100cm SystemRex Medical, L.P. · 2015
  • K141617Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2014
  • K133243Option Elite Vena Cava Filter SystemRex Medical, L.P. · 20132 recalls
  • K120346Cleaner Rotational Thrombectomy SystemRex Medical · 2012

All 13 as Rex Medical →All 9 as Rex Medical, L.P. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K133243Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The…Sep 12, 2025Class II
  • K133243Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter…Jun 8, 2023Class II
  • K023847UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32…Jun 5, 2014Class II
  • K023847UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm)…Jun 5, 2014Class II
  • K023847UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32…Jun 5, 2014Class II
  • K031610ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit…Jul 12, 2004