FDA applicant
Aci Medical, Inc.
FDA records 7 decisions for Aci Medical, Inc. (Sun Valley, CA) from 1985 to 2014: 7 510(k) clearances. Most are in product codes JOW (Sleeve, Limb, Compressible) and LLK (Legging, Compression, Non-Inflatable). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Aci Medical, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Aci Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Aci 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