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CardioChek 5700411

by Henry Schein, Inc.

CardioChek 5700411 is a Class I 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 00304040037713), 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 Number00304040037713 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 00304040037713 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 00304040037713
  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  • Withdrawn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 clinical chemistry analyser IVD, point-of-care
Model / Ref / Catalog
5700411
Primary DI / UDI-DI
00304040037713
510(k) Number
FDA product code
CHH, JGY, LBR, NBW, CGA
GMDN term
Multiple clinical chemistry analyser IVD, point-of-care
Device class
Class I
Regulation number
862.1175, 862.1705, 862.1475, 862.1345
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple clinical chemistry analyser IVD, point-of-care

Cleared under the same submission (K140068)

and 7 more cleared under K140068

Similar devices

Other devices filed under FDA product code CHH (ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL).

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Prescription use
  • Over-the-counter
  • Serial number
Other properties (12, all answered No)