Skip to content

Verify PCC006

by Albert Browne, Ltd.

Verify PCC006 is a Class II device made by Albert Browne, Ltd., cleared under FDA 510(k) K162758 on 21 Mar 2017 (1 earlier submission) and listed in FDA GUDID since 6 Sep 2016 (UDI-DI 10724995084650), 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

Recall on shared 510(k) K070461; other models may be affected

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162758 Date21 Mar 2017DecidedStatusActive
United StatesGUDID listing Number10724995084650 UDI-DI Date6 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162758 decided 21 Mar 2017 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10724995084650 listed 6 Sep 2016 Listed

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1793-2022 FDA Class III initiated 25 May 2022 on shared 510(k) K070461

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

    • Terminated Z-1736-2022 FDA Class III initiated 10 Aug 2022

    Product contains incorrect chemical indicators in packaging.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

5 dated events

  1. Cleared FDA 510(k) K070461
  2. Listed FDA GUDID 10724995084650
  3. Cleared FDA 510(k) K162758
  4. Recall initiated FDA recalls Z-1793-2022
  5. Recall initiated FDA recalls Z-1736-2022

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Verify
Generic name
Chemical/physical sterilization process indicator
Model / Ref / Catalog
PCC006
Primary DI / UDI-DI
10724995084650
510(k) Number
FDA product code
JOJ
GMDN term
Chemical/physical sterilization process indicator
Device class
Class II
Regulation number
880.2800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Chemical/physical sterilization process indicator

Cleared under the same submission (K070461)

and 1 more cleared under K070461

Cleared under the same submission (K162758)

and 8 more cleared under K162758

Similar devices in this category

Other devices filed under Chemical/physical sterilization process indicator.

Other devices from Albert Browne, Ltd.

See all devices from Albert Browne, Ltd. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)