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Spirit

by CAIRE Inc. 5 variants

Ref 11897386

Spirit (11897386) is a Class IIa device made by Caire Inc., registered in EUDAMED on 12 Mar 2025 (Basic UDI-DI B-M766118973860) and cleared under FDA 510(k) K050153 on 15 Apr 2005, active as of 24 Oct 2026.

Active European Union and United States

CE MDD 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) K050153↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-M766118973860 Basic UDI-DI M766118973860UDI-DIDate12 Mar 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK050153 Date15 Apr 2005IssuedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-M766118973860 registered 12 Mar 2025 Active
  • FDA 510(k) K050153 decided 15 Apr 2005 Active

Recalls

1 recall · FDA

    • Terminated Z-1716-2008 FDA Unclassified (pre-2012) initiated 23 Oct 2007 on shared 510(k) K050153

    Moisture ingress into the electronic liquid level indicator may cause inaccurate liquid oxygen level readings. The oxygen could run out without the patient knowledge.

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K050153
  2. Recall initiated FDA recalls Z-1716-2008
  3. Registered EUDAMED B-M766118973860

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Device name
Fnl Spirit 1200T Tf Pb F 5LPM
Model / reference
11897386
Primary DI / UDI-DI
M766118973860
Basic UDI-DI
B-M766118973860
EMDN code
R9099 Respiratory and anaesthesia devices - other
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000013030
Authorised representative
MPS Medical Product Service GmbH DE-AR-000005009

Related devices

Category: Pulmonary function analysis system, adult

Similar devices in this category

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Properties

Other properties (12, all answered No)