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Invos PMC71V-Sf

by Covidien LP

Ref PMC71V-SF

Invos PMC71V-Sf is a device classified as Class IIb in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 31 Jul 2026 (Basic UDI-DI 0763000B00028238G), cleared under FDA 510(k) K211561 on 5 Dec 2021 and listed in FDA GUDID since 8 Feb 2025 (UDI-DI 10884521845039), active as of 23 Oct 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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211561

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00028238G Basic UDI-DI 10884521845039UDI-DIDate31 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521845039 UDI-DI Date8 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK211561 Date5 Dec 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00028238G registered 31 Jul 2026 Active
  • FDA 510(k) K211561 decided 5 Dec 2021 Active
  • FDA GUDID UDI-DI 10884521845039 listed 8 Feb 2025 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1731-2024 FDA Class II initiated 9 Jan 2024

    manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel

Timeline

4 dated events

  1. Cleared FDA 510(k) K211561
  2. Recall initiated FDA recalls Z-1731-2024
  3. Listed FDA GUDID 10884521845039
  4. Registered EUDAMED 0763000B00028238G

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  • Withdrawn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
Invos
Generic name
Tissue saturation oximeter
Device name
INVOS rSO2 preamplifier
Model / reference
PMC71V-SF
Primary DI / UDI-DI
10884521845039
Basic UDI-DI
0763000B00028238G
510(k) Number
FDA product code
MUD
EMDN code
Z1203020407 Subcutaneous oximeters
GMDN term
Tissue saturation oximeter
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.2700
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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: Cerebral oximeterTissue saturation oximeter

Cleared under the same submission (K211561)

and 8 more cleared under K211561

Similar devices in this category

Other devices filed under GASEOUS EXCHANGE MONITORING INSTRUMENTS.

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Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)