510(k) Report

FDA applicant

Surefire Medical, Inc.

Westminster, CO10 decisions2011–20180 recalls

FDA records 10 decisions for Surefire Medical, Inc. (Westminster, CO) from 2011 to 2018: 10 510(k) clearances. Most are in product codes DQO (Catheter, Intravascular, Diagnostic) and DQY (Catheter, Percutaneous). Since 2016 its 510(k)s took a median of 14 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 8 of them its own earlier devices. No recall is linked to its devices.

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

FDA decisions per year

1in 2018

2011: 12012: 32014: 12015: 12016: 22017: 12018: 1
2011high 3 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Surefire Medical, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Surefire Medical, 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?

  • DQOCatheter, Intravascular, Diagnostic7decisions
  • DQYCatheter, Percutaneous2decisions
  • DQXWire, Guide, Catheter1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 14 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 147 days; 4 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 8 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.

  • K140034Surefire Guiding CatheterSurefire Medical, Inc. · 20142cite it
  • K171355Surefire Precision Infusion SystemSurefire Medical, Inc. · 20172cite it
  • K143588Surefire Infusion System 021Surefire Medical, Inc. · 20152cite it
  • K110459Surefire Infusion Catheter SystemSurefire Medical, Inc. · 20112cite it
  • K121677Surefire HI-Flow MicrocatheterSurefire Medical, Inc. · 20121cites it
  • K160662Surefire Infusion SystemSurefire Medical, Inc. · 20161cites it

What has FDA decided for it lately?

  • K180677Surefire Spark Infusion SystemSurefire Medical, Inc. · 2018
  • K171355Surefire Precision Infusion SystemSurefire Medical, Inc. · 2017
  • K162359Surefire Guiding CatheterSurefire Medical, Inc. · 2016
  • K160662Surefire Infusion SystemSurefire Medical, Inc. · 2016
  • K143588Surefire Infusion System 021Surefire Medical, Inc. · 2015
  • K140034Surefire Guiding CatheterSurefire Medical, Inc. · 2014
  • K122506Surefire High Flow Angiographic Catheter, AccessSurefire Medical, Inc. · 2012
  • K121677Surefire HI-Flow MicrocatheterSurefire Medical, Inc. · 2012

All 10 as Surefire Medical, Inc. →