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Insert Earphone PIEP monaural 100867

by PATH medical GmbH

Ref 100867

Insert Earphone PIEP monaural 100867 is a device classified as Class IIa in the EU and Class II in the US made by PATH medical GmbH, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 0426022Earphones-2aQ9), cleared under FDA 510(k) K133012 on 9 Jun 2014 and listed in FDA GUDID since 31 Dec 2017 (UDI-DI 04260223143090), active as of 25 Oct 2026.

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

4 ongoing

Recall on shared 510(k) K133012; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K133012

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 Number0426022Earphones-2aQ9 Basic UDI-DI 04260223143090UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260223143090 UDI-DI Date31 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK133012 Date9 Jun 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0426022Earphones-2aQ9 registered 28 May 2026 Active
  • FDA 510(k) K133012 decided 9 Jun 2014 Active
  • FDA GUDID UDI-DI 04260223143090 listed 31 Dec 2017 Listed

Recalls

4 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-0403-2024 FDA Class II initiated 26 Sep 2023 on shared 510(k) K133012
    • Ongoing Z-0401-2024 FDA Class II initiated 26 Sep 2023 on shared 510(k) K133012
    • Ongoing Z-0404-2024 FDA Class II initiated 26 Sep 2023 on shared 510(k) K133012
    • Ongoing Z-0402-2024 FDA Class II initiated 26 Sep 2023 on shared 510(k) K133012

    Affected lots of product may experience technical distortions to a greater extent than expected.

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

Timeline

7 dated events

  1. Cleared FDA 510(k) K133012
  2. Listed FDA GUDID 04260223143090
  3. Recall initiated FDA recalls Z-0403-2024
  4. Recall initiated FDA recalls Z-0401-2024
  5. Recall initiated FDA recalls Z-0404-2024
  6. Recall initiated FDA recalls Z-0402-2024
  7. Registered EUDAMED 0426022Earphones-2aQ9

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
Ip-05M EUDAMED
Insert Earphone PIEP monaural GUDID
Generic name
Evoked-potential audiometer
Device name
Insert Earphones
Model / reference
100867
Primary DI / UDI-DI
04260223143090
Basic UDI-DI
0426022Earphones-2aQ9
510(k) Number
FDA product code
ETY
EMDN code
Z12149080 Various ENT instruments - hardware accessories
GMDN term
Evoked-potential audiometer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.1090
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Evoked-potential audiometer

Cleared under the same submission (K133012)

and 8 more cleared under K133012

Similar devices in this category

Other devices filed under VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from PATH medical GmbH

See all devices from PATH medical GmbH →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)