FDA applicant
Aed Battery Exchange, LLC
FDA records 2 decisions for Aed Battery Exchange, LLC (Wauconda) from 2012 to 2021: 1 510(k) clearance and 1 original PMA approval. All are in product code MKJ (Automated External Defibrillators (Non-Wearable)). Its devices cite 12 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Aed Battery Exchange, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Aed Battery Exchange, LLC’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