510(k) Report

FDA applicant

Radius Medical Technologies, Inc.

Hopkonton, MA9 decisions1997–20074 recalls

FDA records 9 decisions for Radius Medical Technologies, Inc. (Hopkonton, MA) from 1997 to 2007: 9 510(k) clearances. Most are in product codes MMX (Device, Percutaneous Retrieval) and DQX (Wire, Guide, Catheter). Its devices cite 10 predicates, 7 of them its own earlier devices. 4 recalls are linked to its devices, 4 Class I.

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 Radius Medical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

4in 2013

2013: 4, 4 Class I
2007high 4 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Radius Medical Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MMXDevice, Percutaneous Retrieval3decisions
  • DQXWire, Guide, Catheter3decisions
  • DQYCatheter, Percutaneous1decision
  • LITCatheter, Angioplasty, Peripheral, Transluminal1decision
  • OCYEndoscopic Guidewire, Gastroenterology-Urology1decision

Whose devices does it build on?

Its devices cite 10 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 times; 7 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.

  • K970466Radius Ptca GuidewireRadius Medical Technologies, Inc. · 19975cite it
  • K011287Radius Cougar WireRadius Medical Technologies, Inc. · 20014cite it
  • K071457Modification to Radius SnareRadius Medical Technologies, Inc. · 20072cite it
  • K021441Radius SnareRadius Medical Technologies, Inc. · 20022cite it
  • K011759Radius Next Generation GuidewireRadius Medical Technologies, Inc. · 20012cite it
  • K032129Radius 018 Cougar WireRadius Medical Technologies, Inc. · 20032cite it

What has FDA decided for it lately?

  • K070502Radius SnareRadius Medical Technologies, Inc. · 2007
  • K071457Modification to Radius SnareRadius Medical Technologies, Inc. · 2007
  • K032899Radius Cougar WireRadius Medical Technologies, Inc. · 20032 Class I recalls
  • K032129Radius 018 Cougar WireRadius Medical Technologies, Inc. · 2003
  • K022201Radius Micro SnareRadius Medical Technologies, Inc. · 2003
  • K021441Radius SnareRadius Medical Technologies, Inc. · 2002
  • K011759Radius Next Generation GuidewireRadius Medical Technologies, Inc. · 2001
  • K011287Radius Cougar WireRadius Medical Technologies, Inc. · 2001

All 9 as Radius Medical Technologies, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K970466THUNDER Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable guide…Oct 21, 2013Class I
  • K970466THUNDER Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, THNDR300S…Oct 21, 2013Class I
  • K032899COUGAR Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S Medtronic…Oct 21, 2013Class I
  • K032899Cougar Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S…Oct 21, 2013Class I

Other applicant names beginning “Radius”

FDA records each applicant name separately; these may or may not be the same firm.

Radius Intl., Inc. 5Radius Medical, LLC 1