FDA applicant
Ackrad Laboratories
FDA records 42 decisions for Ackrad Laboratories (Cranford, NJ) from 1979 to 2002: 42 510(k) clearances. Most are in product codes LKF (Cannula, Manipulator/Injector, Uterine) and BZD (Ventilator, Non-Continuous (Respirator)). Its devices cite 6 predicates, 5 of them its own earlier devices. 6 recalls are linked to its devices, 2 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ackrad Laboratories’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ackrad Laboratories since 2007.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like Ackrad Laboratories’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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