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Neonatal flow sensor insert 8410179

by Drägerwerk AG & Co. KGaA

Ref 8410179Model 306009XK19T010

Neonatal flow sensor insert 8410179 is a device classified as Class IIb in the EU and Class II in the US made by Drägerwerk AG & Co. KGaA, registered in EUDAMED on 1 Jun 2026 (Basic UDI-DI 040486751306009XK19T010DR), cleared under FDA 510(k) K974176 on 17 Jun 1998 and listed in FDA GUDID since 8 Apr 2022 (UDI-DI 04048675448853), active as of 12 Nov 2026. One FDA recall is 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

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K974176

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 Number040486751306009XK19T010DR Basic UDI-DI 04048675448853UDI-DIDate1 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048675448853 UDI-DI Date8 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK974176 Date17 Jun 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 040486751306009XK19T010DR registered 1 Jun 2026 Active
  • FDA 510(k) K974176 decided 17 Jun 1998 Active
  • FDA GUDID UDI-DI 04048675448853 listed 8 Apr 2022 Listed

Recalls

1 recall · FDA

    • Terminated Z-0515-06 FDA Unclassified (pre-2012) initiated 28 Dec 2005

    Failure to generate an alarm when an unintended disconnection occurrs

Timeline

4 dated events

  1. Cleared FDA 510(k) K974176
  2. Recall initiated FDA recalls Z-0515-06
  3. Listed FDA GUDID 04048675448853
  4. Registered EUDAMED 040486751306009XK19T010DR

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  • Withdrawn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
Neonataler Flowsensor-Einsatz (5x) EUDAMED
Neonatal flow sensor insert GUDID
Generic name
Breathing circuit gas-flow sensor, reusable
Model / reference
8410179, 306009XK19T010
Primary DI / UDI-DI
04048675448853
Basic UDI-DI
040486751306009XK19T010DR
Direct marketing DI
04048675448853
FDA product code
CBK
EMDN code
Z1203019080 Various instruments for anaesthesia and pulmonary ventilation support - hardware accessories
GMDN term
Breathing circuit gas-flow sensor, reusable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.5895
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 IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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 gas-flow sensor, reusable

Cleared under the same submission (K974176)

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES.

Other devices from Drägerwerk AG & Co. KGaA

See all devices from Drägerwerk AG & Co. KGaA →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (23, all answered No)