FDA applicant

Guidepath Medical, Inc.

Austin, TX1 decision2012–201212 recalls

FDA records 1 decision for Guidepath Medical, Inc. (Austin, TX) in 2012: 1 510(k) clearance. All are in product code DQX (Wire, Guide, Catheter). Its devices cite 3 predicates, 0 of them its own earlier devices. 12 recalls are linked to its devices, 12 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 Guidepath Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

12in 2014

2012high 12 (2014) · low 0 (2012)2026

Class I Class II/III not classified

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

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Guidepath Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?