510(k) Report

FDA applicant

Roxwood Medical, Inc.

Redwood City, CA8 decisions2012–20170 recalls

FDA records 8 decisions for Roxwood Medical, Inc. (Redwood City, CA) from 2012 to 2017: 8 510(k) clearances. All are in product code DQY (Catheter, Percutaneous). Since 2016 its 510(k)s took a median of 124 days from receipt to decision, against 117 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 6 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 Roxwood Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2012: 12014: 12015: 22016: 32017: 1
2012high 3 (2016) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Roxwood Medical, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Roxwood 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?

  • DQYCatheter, Percutaneous8decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 124 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 117 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 6 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.

  • K121763Multicross Support CatheterRoxwood Medical, Inc. · 20123cite it
  • K140910Centercross CatheterRoxwood Medical, Inc. · 20141cites it
  • K152456CenterCross Ultra CatheterRoxwood Medical, Inc. · 20161cites it
  • K160681CenterCross Ultra CatheterRoxwood Medical, Inc. · 20161cites it
  • K143744MicroCross CatheterRoxwood Medical, Inc. · 20151cites it

What has FDA decided for it lately?

  • K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc. · 2017
  • K160681CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016
  • K152957MultiCross CatheterRoxwood Medical, Inc. · 2016
  • K152456CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016
  • K151082MicroCross CatheterRoxwood Medical, Inc. · 2015
  • K143744MicroCross CatheterRoxwood Medical, Inc. · 2015
  • K140910Centercross CatheterRoxwood Medical, Inc. · 2014
  • K121763Multicross Support CatheterRoxwood Medical, Inc. · 2012

All 8 as Roxwood Medical, Inc. →