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CardioChek 4000023

by Henry Schein, Inc.

CardioChek 4000023 is a Class II device made by Henry Schein, Inc., cleared under FDA 510(k) K140068 on 22 May 2015 and listed in FDA GUDID since 5 Jan 2017 (UDI-DI 90304040038522), active as of 23 Oct 2026. 4 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

4 closed

Documents

510(k) K140068

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 Number90304040038522 UDI-DI Date5 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK140068 Date22 May 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K140068 decided 22 May 2015 Active
  • FDA GUDID UDI-DI 90304040038522 listed 5 Jan 2017 Listed

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0833-2020 FDA Class II initiated 2 Dec 2019
    • Terminated Z-0835-2020 FDA Class II initiated 2 Dec 2019
    • Terminated Z-0834-2020 FDA Class II initiated 2 Dec 2019
    • Terminated Z-0832-2020 FDA Class II initiated 2 Dec 2019

    One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.

Timeline

6 dated events

  1. Cleared FDA 510(k) K140068
  2. Listed FDA GUDID 90304040038522
  3. Recall initiated FDA recalls Z-0833-2020
  4. Recall initiated FDA recalls Z-0835-2020
  5. Recall initiated FDA recalls Z-0834-2020
  6. Recall initiated FDA recalls Z-0832-2020

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CardioChek
Generic name
Multiple lipid analyte IVD, kit, multiple technologies
Model / Ref / Catalog
4000023
Primary DI / UDI-DI
90304040038522
510(k) Number
FDA product code
NBW, CGA
GMDN term
Multiple lipid analyte IVD, kit, multiple technologies
Device class
Class II
Regulation number
862.1345
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple lipid analyte IVD, kit, multiple technologies

Cleared under the same submission (K140068)

and 7 more cleared under K140068

Similar devices

Other devices filed under FDA product code NBW (SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER).

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Single use
  • Prescription use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)