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Penumbra System IAPS2

by Penumbra, Inc.

Ref IAPS2Model Non-Sterile Pump MAX Supplies – Indigo System

Penumbra System IAPS2 is a device classified as Class I in the EU and Class II in the US made by Penumbra, Inc., registered in EUDAMED on 26 May 2026 (Basic UDI-DI 081454801INDSUP9R), cleared under FDA 510(k) K122756 on 2 Oct 2012 and listed in FDA GUDID since 30 Jul 2016 (UDI-DI 00810169721834), active as of 22 Oct 2026.

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 found

in data synced 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K122756

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081454801INDSUP9R Basic UDI-DI 00810169721834UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810169721834 UDI-DI Date30 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK122756 Date2 Oct 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081454801INDSUP9R registered 26 May 2026 Active
  • FDA 510(k) K122756 decided 2 Oct 2012 Active
  • FDA GUDID UDI-DI 00810169721834 listed 30 Jul 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K122756
  2. Listed FDA GUDID 00810169721834
  3. Registered EUDAMED 081454801INDSUP9R

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  • Withdrawn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
Non-Sterile Pump MAX Supplies – Indigo System EUDAMED
Penumbra System GUDID
Generic name
Surgical irrigation/aspiration system
Device name
Pump MAX Canister
Model / reference
IAPS2, Non-Sterile Pump MAX Supplies – Indigo System
Primary DI / UDI-DI
00810169721834 EUDAMED
00814548013343 GUDID
Basic UDI-DI
081454801INDSUP9R
510(k) Number
FDA product code
JCX
EMDN code
A060199 Surgical drainage systems - other
GMDN term
Surgical irrigation/aspiration system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4780
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00810169721834
GUDID
00814548013343
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00810169721834; FDA GUDID lists 00814548013343), so their flags are not compared. Device class is stated on each registry's own scale: Class I 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: Surgical irrigation/aspiration system

Cleared under the same submission (K122756)

and 1 more cleared under K122756

Similar devices in this category

Other devices filed under SURGICAL DRAINAGE SYSTEMS - OTHER.

Other devices from Penumbra, Inc.

See all devices from Penumbra, Inc. →

Properties

  • Single use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)