510(k) Report

FDA applicant

Km Corporation

Anaheim, CA4 decisions2014–20240 recalls

FDA records 4 decisions for Km Corporation (Anaheim, CA) from 2014 to 2024: 4 510(k) clearances. Most are in product codes KIF (Resin, Root Canal Filling) and FRG (Wrap, Sterilization). Its devices cite 8 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Km Corp.”.

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

FIG. A — Illustration, dental panel, where it files most

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

FDA decisions per year

1in 2024

2014: 32024: 1
2014high 3 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Km Corporation by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Km Corporation’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