Skip to content

Integra® BAT1001

by Integra Lifesciences (Ireland) Limited

Integra® BAT1001 is a Class II device made by Integra Lifesciences (Ireland) Limited, cleared under FDA 510(k) K121573 on 10 Sep 2012 and listed in FDA GUDID since 23 May 2018 (UDI-DI 10381780202950), active as of 23 Oct 2026. 3 FDA recalls are 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

None ongoing

3 closed

Documents

510(k) K121573

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 Number10381780202950 UDI-DI Date23 May 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK121573 Date10 Sep 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121573 decided 10 Sep 2012 Active
  • FDA GUDID UDI-DI 10381780202950 listed 23 May 2018 Listed

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1619-2015 FDA Class II initiated 14 Apr 2015
    • Terminated Z-1620-2015 FDA Class II initiated 14 Apr 2015

    Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.

    • Terminated Z-1618-2015 FDA Class II initiated 14 Apr 2015

    Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.

Timeline

5 dated events

  1. Cleared FDA 510(k) K121573
  2. Recall initiated FDA recalls Z-1619-2015
  3. Recall initiated FDA recalls Z-1620-2015
  4. Recall initiated FDA recalls Z-1618-2015
  5. Listed FDA GUDID 10381780202950

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Integra®
Generic name
Portable/mobile rechargeable battery pack
Model / Ref / Catalog
BAT1001
Primary DI / UDI-DI
10381780202950
510(k) Number
FDA product code
GWM
GMDN term
Portable/mobile rechargeable battery pack
Device class
Class II
Regulation number
882.1620
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Portable/mobile rechargeable battery pack

Cleared under the same submission (K121573)

and 8 more cleared under K121573

Similar devices in this category

Other devices filed under Portable/mobile rechargeable battery pack.

Other devices from Integra Lifesciences (Ireland) Limited

See all devices from Integra Lifesciences (Ireland) Limited →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)