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AutoPulse Battery 100

by ZOLL Circulation, Inc. 17 variants

AutoPulse Battery 100 (8700-0702-16) is a Class II device made by ZOLL Circulation, Inc., cleared under FDA 510(k) K112998 on 15 Mar 2012 and listed in FDA GUDID since 24 Jul 2015 (UDI-DI 00849111002080), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K112998

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00849111002080 UDI-DI Date24 Jul 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK112998 Date15 Mar 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112998 decided 15 Mar 2012 Active
  • FDA GUDID UDI-DI 00849111002080 listed 24 Jul 2015 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0118-2023 FDA Class II initiated 22 Sep 2022

    Due to increase in Li-Ion Battery failures

Timeline

3 dated events

  1. Cleared FDA 510(k) K112998
  2. Listed FDA GUDID 00849111002080
  3. Recall initiated FDA recalls Z-0118-2023

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AutoPulse Battery
Generic name
Secondary battery
Model / Ref / Catalog
100, 8700-0702-16
Primary DI / UDI-DI
00849111002080
510(k) Number
FDA product code
DRM
GMDN term
Secondary battery
Device class
Class II
Regulation number
870.5200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Secondary battery

Cleared under the same submission (K112998)

and 8 more cleared under K112998

Other devices from ZOLL Circulation, Inc.

See all devices from ZOLL Circulation, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)