510(k) Report

FDA applicant

Devon Medical, Inc.

King Of Prussia, PA13 decisions2009–20140 recalls

FDA records 13 decisions for Devon Medical, Inc. (King Of Prussia, PA) from 2009 to 2014: 13 510(k) clearances. Most are in product codes JOW (Sleeve, Limb, Compressible) and OMP (Negative Pressure Wound Therapy Powered…). Its devices cite 30 predicates, 9 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Devon Medical”.

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

FDA decisions per year

3in 2014

2009: 12010: 32013: 62014: 3
2009high 6 (2013) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Devon Medical, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Devon 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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Other applicant names beginning “Devon”

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