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EV1000 PC2B

by Edwards Lifesciences LLC

Ref PC2B

EV1000 PC2B is a device classified as Class I in the EU and Class II in the US made by Edwards Lifesciences LLC, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI 0690103D001HSA000T3), cleared under FDA 510(k) K160552 on 1 Jun 2016 (1 earlier submission) and listed in FDA GUDID since 3 Sep 2016 (UDI-DI 00690103193480), active as of 24 Oct 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

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160552

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0690103D001HSA000T3 Basic UDI-DI 00690103193480UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00690103193480 UDI-DI Date3 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK160552 Date1 Jun 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0690103D001HSA000T3 registered 30 Sep 2026 Active
  • FDA 510(k) K160552 decided 1 Jun 2016 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00690103193480 listed 3 Sep 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-1193-2019 FDA Class I initiated 21 Mar 2019

    Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.

    • Terminated Z-1732-2015 FDA Class II initiated 18 May 2015

    Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.

Timeline

6 dated events

  1. Cleared FDA 510(k) K140312
  2. Recall initiated FDA recalls Z-1732-2015
  3. Cleared FDA 510(k) K160552
  4. Listed FDA GUDID 00690103193480
  5. Recall initiated FDA recalls Z-1193-2019
  6. Registered EUDAMED 0690103D001HSA000T3

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
EV1000
Generic name
Electrical cable/lead holder
Device name
HemoSphere Accessories
Model / Ref / Catalog
PC2B
Primary DI / UDI-DI
00690103193480
Basic UDI-DI
0690103D001HSA000T3
510(k) Number
FDA product code
DSB, DXN
EMDN code
Z1203020280 Multi-parameter monitors - hardware accessories
GMDN term
Electrical cable/lead holder
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.2770, 870.1130
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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: Electrical cable/lead holder

Cleared under the same submission (K140312)

and 8 more cleared under K140312

Cleared under the same submission (K160552)

and 8 more cleared under K160552

Similar devices in this category

Other devices filed under MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES.

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)