510(k) Report

FDA applicant

Pinnacle Products, Inc.

St. Paul, MN1 decision1997–19973 recalls

FDA records 1 decision for Pinnacle Products, Inc. (St. Paul, MN) in 1997: 1 510(k) clearance. All are in product code MMP (Cover, Barrier, Protective). Its devices cite 3 predicates, 0 of them its own earlier devices. 3 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 Pinnacle Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pinnacle Products, Inc. since 2007.

Recalls per year

2in 2015

2011: 12015: 2
2007high 2 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Pinnacle Products, 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 “Pinnacle”

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