510(k) Report

FDA applicant

Nexus Medical, LLC

Lenexa, KS16 decisions2003–20150 recalls

FDA records 16 decisions for Nexus Medical, LLC (Lenexa, KS) from 2003 to 2015: 16 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and LJH (System, Irrigation, Urological). 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, general hospital panel, where it files most

How often FDA has decided Nexus Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2008: 22010: 32012: 12013: 22014: 12015: 1
2007high 3 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Nexus Medical, 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

Other applicant names beginning “Nexus”

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