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Filter CareStar 20 Plus MP05770

by Drägerwerk AG & Co. KGaA

Ref MP05770Model 2080436K19S030

Filter CareStar 20 Plus MP05770 is a microbial medical gas filter (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 27 May 2026 (Basic UDI-DI 0404867512080436K19S030SB), cleared under FDA 510(k) K221836 on 7 Dec 2022 and listed in FDA GUDID since 9 Jan 2023 (UDI-DI 04048675665748), 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 Number0404867512080436K19S030SB Basic UDI-DI 04048675665748UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048675665748 UDI-DI Date9 Jan 2023ListedStatusListed 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 0404867512080436K19S030SB registered 27 May 2026 Active
  • FDA 510(k) K221836 decided 7 Dec 2022 Active
  • FDA GUDID UDI-DI 04048675665748 listed 9 Jan 2023 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 04048675665748
  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 0404867512080436K19S030SB

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
Filter CareStar 20 Plus
Generic name
Microbial medical gas filter, single-use
Model / reference
MP05770, 2080436K19S030
Primary DI / UDI-DI
04048675665748
Basic UDI-DI
0404867512080436K19S030SB
510(k) Number
FDA product code
CAH
EMDN code
R040101 Antibacterial and antiviral respiratory filters
GMDN term
Microbial medical gas filter, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5260
EU registration type
Standard device
EU market of registration
Germany
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: Microbial medical gas filter, single-use

Cleared under the same submission (K221836)

and 6 more cleared under K221836

Similar devices in this category

Other devices filed under ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS.

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 (21, all answered No)