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Clearsight Cscm

by Edwards Lifesciences LLC

Part of a family of 11 devices: see the family page

Ref CSCM

Clearsight Cscm is a device classified as Class IIa in the EU and Class II in the US made by Edwards Lifesciences LLC, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI 0690103D001FCA000LR), cleared under FDA 510(k) K182245 on 30 Nov 2018 (2 earlier submissions) and listed in FDA GUDID since 3 Sep 2016 (UDI-DI 00690103193350), 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) K182245

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0690103D001FCA000LR Basic UDI-DI 00690103193350UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182245 Date30 Nov 2018DecidedStatusActive
United StatesGUDID listing GUDID Number00690103193350 UDI-DI Date3 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0690103D001FCA000LR registered 1 Oct 2026 Active
  • FDA 510(k) K182245 decided 30 Nov 2018 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00690103193350 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

7 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 00690103193350
  5. Cleared FDA 510(k) K182245
  6. Recall initiated FDA recalls Z-1193-2019
  7. Registered EUDAMED 0690103D001FCA000LR

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
Clearsight
Generic name
Blood pressure cuff, single-use
Device name
Non-Invasive Finger Cuff
Model / Ref / Catalog
CSCM
Primary DI / UDI-DI
00690103193350
Basic UDI-DI
0690103D001FCA000LR
510(k) Number
FDA product code
DXN, DSB
EMDN code
Z1203020302 Non–invasive blood pressure monitoring instruments
GMDN term
Blood pressure cuff, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1130, 870.2770
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 IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Blood pressure cuff, single-use

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 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS.

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)