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Integra® PMIOMPM-1

by Integra Lifesciences (Ireland) Limited

Part of a family of 24 devices: see the family page

Ref PMIOMPM-1

Integra® PMIOMPM-1 is a device classified as Class I in the EU and Class II in the US made by Integra Lifesciences (Ireland) Limited, registered in EUDAMED on 8 Jul 2026 (Basic UDI-DI 038178B0036CSS3D), cleared under FDA 510(k) K121573 on 10 Sep 2012 and listed in FDA GUDID since 30 May 2018 (UDI-DI 10381780466291), active as of 25 Oct 2026. 3 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K121573

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038178B0036CSS3D Basic UDI-DI 10381780466291UDI-DIDate8 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780466291 UDI-DI Date30 May 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK121573 Date10 Sep 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 038178B0036CSS3D registered 8 Jul 2026 Active
  • FDA 510(k) K121573 decided 10 Sep 2012 Active
  • FDA GUDID UDI-DI 10381780466291 listed 30 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

6 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 10381780466291
  6. Registered EUDAMED 038178B0036CSS3D

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Integra®
Generic name
Electrical-only medical device connection cable, reusable
Device name
lntegra Monitor cables
Model / Ref / Catalog
PMIOMPM-1
Primary DI / UDI-DI
10381780466291
Basic UDI-DI
038178B0036CSS3D
510(k) Number
FDA product code
GWM
EMDN code
L99 Surgical instruments, reusable - other
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1620
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electrical-only medical device connection cable, reusable

Cleared under the same submission (K121573)

and 8 more cleared under K121573

Similar devices in this category

Other devices filed under SURGICAL INSTRUMENTS, REUSABLE - OTHER.

Other devices from Integra Lifesciences (Ireland) Limited

See all devices from Integra Lifesciences (Ireland) Limited →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)