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BladderScan® i10™

by Verathon Inc 3 variants

Ref 0570-0412

BladderScan® i10™ (0570-0412) is a device classified as Class IIa in the EU and Class II in the US made by Verathon Inc, registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI 087912300-0011JV), cleared under FDA 510(k) K172356 on 15 Sep 2017 and listed in FDA GUDID since 21 May 2021 (UDI-DI 00879123007438), active as of 8 Nov 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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172356

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number087912300-0011JV Basic UDI-DI 00879123007438UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00879123007438 UDI-DI Date21 May 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK172356 Date15 Sep 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 087912300-0011JV registered 14 Oct 2026 Active
  • FDA 510(k) K172356 decided 15 Sep 2017 Active
  • FDA GUDID UDI-DI 00879123007438 listed 21 May 2021 Listed

Recalls

1 recall · FDA

    • Terminated Z-0531-2021 FDA Class II initiated 29 Sep 2020 on shared 510(k) K172356

    Due to a change in handle material and process, probe handle may crack.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K172356
  2. Recall initiated FDA recalls Z-0531-2021
  3. Listed FDA GUDID 00879123007438
  4. Registered EUDAMED 087912300-0011JV

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  • Withdrawn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
BladderScan i10 EUDAMED
BladderScan® GUDID
Generic name
General-purpose ultrasound imaging system
Device name
Bladder Volume Measurement Ultrasound Probes & Consoles
Model / Ref / Catalog
0570-0412, i10™
Primary DI / UDI-DI
00879123007438
Basic UDI-DI
087912300-0011JV
510(k) Number
FDA product code
IYO
EMDN code
Z12080304 Ultrasonic bladder volume scanners
GMDN term
General-purpose ultrasound imaging system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1560
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
0570-0412
GUDID
i10™
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: General-purpose ultrasound imaging system

Cleared under the same submission (K172356)

and 4 more cleared under K172356

Similar devices in this category

Other devices filed under ULTRASONIC BLADDER VOLUME SCANNERS.

Other devices from Verathon Inc

See all devices from Verathon Inc →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)