510(k) Report

FDA applicant

Oxford Performance Materials, Inc.

South Windsor, CT6 decisions2013–20190 recalls

FDA records 6 decisions for Oxford Performance Materials, Inc. (South Windsor, CT) from 2013 to 2019: 6 510(k) clearances. Most are in product codes KKY (Material, Polytetrafluoroethylene Vitreous…) and GXN (Plate, Cranioplasty, Preformed, Non-Alterable). Its devices cite 13 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Oxford Performance Materials”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Oxford Performance Materials, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2013: 12014: 12015: 12016: 12018: 12019: 1
2013high 1 (2013) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Oxford Performance Materials, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Oxford Performance Materials, 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 “Oxford”

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