510(k) Report

FDA applicant

Km Products

Tucson, AZ3 decisions1985–19850 recalls

FDA records 3 decisions for Km Products (Tucson, AZ) in 1985: 3 510(k) clearances. Most are in product codes BTA (Pump, Portable, Aspiration (Manual Or Powered)) and JOL (Catheter And Tip, Suction). 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 and plastic surgery panel, where it files most

How often FDA has decided Km Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Km Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Km Products’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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