FDA applicant
Asi Medical, Inc.
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
How often FDA has decided Asi Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2007high 1 (2012) · low 0 (2007)2026
2026 so far, outlined.
Recalls per year
1in 2013
2007high 1 (2013) · low 0 (2007)2026
Class I Class II/III not classified
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.
See the 510(k) Report