FDA applicant
CAO Group, Inc.
FDA records 31 decisions for CAO Group, Inc. (West Jordan, UT) from 2001 to 2026: 31 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and LBH (Varnish, Cavity). Since 2016 its 510(k)s took a median of 206 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 44 predicates, 17 of them its own earlier devices. 12 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided CAO Group, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2020
2026 so far, outlined.
Recalls per year
12in 2007
Class I Class II/III not classified
Planning a device like CAO Group, 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