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Vermed IPC71810

by Graphic Controls Acquisition Corp

Vermed IPC71810 (4009855C) is a Class II device made by Graphic Controls Acquisition Corp, cleared under FDA 510(k) K101685 on 1 Jul 2010 and listed in FDA GUDID since 3 Nov 2017 (UDI-DI 15060441914627), active as of 23 Oct 2026.

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

6 closed

Documents

510(k) K101685

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 Number15060441914627 UDI-DI Date3 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK101685 Date1 Jul 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K101685 decided 1 Jul 2010 Active
  • FDA GUDID UDI-DI 15060441914627 listed 3 Nov 2017 Listed

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-0937-2022 FDA Class II initiated 15 Mar 2022 on shared 510(k) K101685
    • Terminated Z-0940-2022 FDA Class II initiated 15 Mar 2022 on shared 510(k) K101685
    • Terminated Z-0936-2022 FDA Class II initiated 15 Mar 2022 on shared 510(k) K101685
    • Terminated Z-0939-2022 FDA Class II initiated 15 Mar 2022 on shared 510(k) K101685
    • Terminated Z-0938-2022 FDA Class II initiated 15 Mar 2022 on shared 510(k) K101685
    • Terminated Z-0935-2022 FDA Class II initiated 15 Mar 2022 on shared 510(k) K101685

    Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.

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

Timeline

8 dated events

  1. Cleared FDA 510(k) K101685
  2. Listed FDA GUDID 15060441914627
  3. Recall initiated FDA recalls Z-0937-2022
  4. Recall initiated FDA recalls Z-0940-2022
  5. Recall initiated FDA recalls Z-0936-2022
  6. Recall initiated FDA recalls Z-0939-2022
  7. Recall initiated FDA recalls Z-0938-2022
  8. Recall initiated FDA recalls Z-0935-2022

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vermed
Generic name
Patient monitoring system module, electrocardiographic
Model / Ref / Catalog
IPC71810, 4009855C
Primary DI / UDI-DI
15060441914627
510(k) Number
FDA product code
DSA
GMDN term
Patient monitoring system module, electrocardiographic
Device class
Class II
Regulation number
870.2900
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Patient monitoring system module, electrocardiographic

Cleared under the same submission (K101685)

and 8 more cleared under K101685

Other devices from Graphic Controls Acquisition Corp

See all devices from Graphic Controls Acquisition Corp →

Properties

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