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Invos PM7100

by Covidien LP

Ref PM7100

Invos PM7100 is a device classified as Class IIb in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 13 Aug 2026 (Basic UDI-DI 0763000B000337087), cleared under FDA 510(k) K211561 on 5 Dec 2021 (1 earlier submission) and listed in FDA GUDID since 14 Jun 2021 (UDI-DI 10884521810105), active as of 2 Nov 2026. 2 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

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211561

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B000337087 Basic UDI-DI 10884521810105UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK211561 Date5 Dec 2021DecidedStatusActive
United StatesGUDID listing GUDID Number10884521810105 UDI-DI Date14 Jun 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000337087 registered 13 Aug 2026 Active
  • FDA 510(k) K211561 decided 5 Dec 2021 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10884521810105 listed 14 Jun 2021 Listed

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1732-2024 FDA Class II initiated 9 Jan 2024
    • 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

6 dated events

  1. Cleared FDA 510(k) K182868
  2. Listed FDA GUDID 10884521810105
  3. Cleared FDA 510(k) K211561
  4. Recall initiated FDA recalls Z-1732-2024
  5. Recall initiated FDA recalls Z-1731-2024
  6. Registered EUDAMED 0763000B000337087

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  • Withdrawn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
Cerebral oximeter
Device name
INVOS PM7100 Patient Monitor
Model / reference
PM7100
Primary DI / UDI-DI
10884521810105
Basic UDI-DI
0763000B000337087
510(k) Number
FDA product code
MUD
EMDN code
Z1203020407 Subcutaneous oximeters
GMDN term
Cerebral 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 oximeter

Cleared under the same submission (K182868)

and 8 more cleared under K182868

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.

Other devices from Covidien LP

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    Class II

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    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

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