510(k) Report

FDA applicant

Contour Fabricators, Inc.

Grand Blanc, MI8 decisions1979–20095 recalls

FDA records 8 decisions for Contour Fabricators, Inc. (Grand Blanc, MI) from 1979 to 2009: 8 510(k) clearances. Most are in product codes FMQ (Restraint, Protective) and MMP (Cover, Barrier, Protective). Its devices cite 6 predicates, 2 of them its own earlier devices. 5 recalls are 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 and plastic surgery panel, where it files most

How often FDA has decided Contour Fabricators, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

5in 2008

2008: 5
2007high 5 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Contour Fabricators, Inc.’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 “Contour”

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