510(k) Report

FDA applicant

Combat Medical Systems, LLC

Westminster, CO3 decisions2010–20150 recalls

FDA records 3 decisions for Combat Medical Systems, LLC (Westminster, CO) from 2010 to 2015: 3 510(k) clearances. All are in product code DXC (Clamp, Vascular). Its devices cite 3 predicates, 2 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 Combat Medical Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2010: 12013: 12015: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Combat Medical Systems, LLC by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report