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BladderScan® i10™

by Verathon Inc 5 variants

BladderScan® i10™ (0400-0157) is a Class II device made by Verathon Inc, cleared under FDA 510(k) K172356 on 15 Sep 2017 and listed in FDA GUDID since 21 May 2021 (UDI-DI 00879123001511), active as of 8 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K172356

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00879123001511 UDI-DI Date21 May 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172356 Date15 Sep 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172356 decided 15 Sep 2017 Active
  • FDA GUDID UDI-DI 00879123001511 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

3 dated events

  1. Cleared FDA 510(k) K172356
  2. Recall initiated FDA recalls Z-0531-2021
  3. Listed FDA GUDID 00879123001511

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
BladderScan®
Generic name
Noninvasive device battery charger
Model / Ref / Catalog
i10™, 0400-0157
Primary DI / UDI-DI
00879123001511
510(k) Number
FDA product code
IYO
GMDN term
Noninvasive device battery charger
Device class
Class II
Regulation number
892.1560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Noninvasive device battery charger

Cleared under the same submission (K172356)

and 4 more cleared under K172356

Similar devices

Other devices filed under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic).

Other devices from Verathon Inc

See all devices from Verathon Inc →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)