Skip to content

CombiStar Plus Filter flex MP12063

by Drägerwerk AG & Co. KGaA

Ref MP12063Model 2080296K1QZ000

CombiStar Plus Filter flex MP12063 is a breathing circuit catheter mount (EU MDR Class IIa; FDA Class II; FDA product code CAH, Filter, Bacterial, Breathing-Circuit) made by Drägerwerk AG & Co. KGaA, registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI 0404867512080296K1QZ00063), cleared under FDA 510(k) K221836 on 7 Dec 2022 and listed in FDA GUDID since 7 Oct 2024 (UDI-DI 04048675714446), active as of 12 Nov 2026. 4 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

4 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K221836

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0404867512080296K1QZ00063 Basic UDI-DI 04048675714446UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048675714446 UDI-DI Date7 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK221836 Date7 Dec 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0404867512080296K1QZ00063 registered 17 Aug 2026 Active
  • FDA 510(k) K221836 decided 7 Dec 2022 Active
  • FDA GUDID UDI-DI 04048675714446 listed 7 Oct 2024 Listed

Recalls

4 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-2158-2025 FDA Class I initiated 16 Jun 2025
    • Ongoing Z-2159-2025 FDA Class I initiated 16 Jun 2025
    • Ongoing Z-2161-2025 FDA Class I initiated 16 Jun 2025
    • Ongoing Z-2160-2025 FDA Class I initiated 16 Jun 2025

    Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Timeline

7 dated events

  1. Cleared FDA 510(k) K221836
  2. Listed FDA GUDID 04048675714446
  3. Recall initiated FDA recalls Z-2158-2025
  4. Recall initiated FDA recalls Z-2159-2025
  5. Recall initiated FDA recalls Z-2161-2025
  6. Recall initiated FDA recalls Z-2160-2025
  7. Registered EUDAMED 0404867512080296K1QZ00063

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
CombiStar Plus Filter flex
Generic name
Breathing circuit catheter mount, single-use
Model / reference
MP12063, 2080296K1QZ000
Primary DI / UDI-DI
04048675714446
Basic UDI-DI
0404867512080296K1QZ00063
510(k) Number
FDA product code
CAH
EMDN code
R020202, R040102
GMDN term
Breathing circuit catheter mount, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5260
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
The medical purpose of the Pack2Go/Combistar is to support respiratory and anesthetic therapy by ensuring the provision of functionally compatible, and ready-to-use accessories.
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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: Breathing circuit catheter mount, single-use

Cleared under the same submission (K221836)

and 6 more cleared under K221836

Similar devices in this category

Other devices filed under MOBILE CATHETER MOUNTS.

Other devices from Drägerwerk AG & Co. KGaA

See all devices from Drägerwerk AG & Co. KGaA →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)