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BladderScan® Prime

by Verathon Inc 6 variants

BladderScan Prime (0400-0130) is a noninvasive device battery charger (FDA Class II; FDA product code IYO, System, Imaging, Pulsed Echo, Ultrasonic) made by Verathon Inc, cleared under FDA 510(k) K153101 on 19 Nov 2015 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00879123005755), 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 found

in data synced 8 Nov 2026

Documents

510(k) K153101

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 Number00879123005755 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK153101 Date19 Nov 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153101 decided 19 Nov 2015 Active
  • FDA GUDID UDI-DI 00879123005755 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153101
  2. Listed FDA GUDID 00879123005755

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  • Withdrawn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
Prime, 0400-0130
Primary DI / UDI-DI
00879123005755
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 (K153101)

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)