510(k) Report

FDA applicant

Asi Medical, Inc.

Centennial, CO5 decisions1994–20131 recall

FDA records 5 decisions for Asi Medical, Inc. (Centennial, CO) from 1994 to 2013: 5 510(k) clearances. Most are in product codes EIA (Unit, Operative Dental) and KOJ (Airbrush). 1 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, dental panel, where it files most

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

FDA decisions per year

1in 2013

2012: 12013: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Asi Medical, 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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