FDA applicant
ACON Laboratories, Inc.
FDA records 93 decisions for ACON Laboratories, Inc. (San Diego, CA) from 1998 to 2026: 93 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 92 predicates, 53 of them its own earlier devices. 23 recalls are linked to its devices.
FDA’s records also spell it “Acon Laboratories Co.”, “Acon Laboratories”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided ACON Laboratories, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2025
2026 so far, outlined.
Recalls per year
3in 2026
Class I Class II/III not classified
Planning a device like ACON Laboratories, 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