510(k) Report

FDA applicant

Access Battery, Inc.

Elizabeth, CO2 decisions2003–20040 recalls

FDA records 2 decisions for Access Battery, Inc. (Elizabeth, CO) from 2003 to 2004: 2 510(k) clearances. Most are in product codes HGM (System, Monitoring, Perinatal) and MKJ (Automated External Defibrillators (Non-Wearable)). Its devices cite 13 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, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Access Battery, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Access Battery, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Access Battery, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Access Battery, 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

Other applicant names beginning “Access”

FDA records each applicant name separately; these may or may not be the same firm.