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BladderScan® BVI 6000 Series

by Verathon Inc 7 variants

BladderScan BVI 6000 Series (0270-0791) is a bladder volume ultrasound imaging system (FDA Class II; FDA product code IYO, System, Imaging, Pulsed Echo, Ultrasonic) made by Verathon Inc, cleared under FDA 510(k) K022153 on 15 Aug 2002 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10879123004892), 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) K022153

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 Number10879123004892 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK022153 Date15 Aug 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K022153 decided 15 Aug 2002 Active
  • FDA GUDID UDI-DI 10879123004892 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0143-2011 FDA Unclassified (pre-2012) initiated 20 Sep 2010 on shared 510(k) K022153

    Incorrect programming causes QuickPrint to fail to recognize the communication Cradles. As a result, ScanPoint Communications Cradles could not communicate with ScanPoint Online Tool while using the QuickPrint interface. This will affect the transfer of exams and device calibration through QuickPrint interface.

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) K022153
  2. Recall initiated FDA recalls Z-0143-2011
  3. Listed FDA GUDID 10879123004892

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  • Withdrawn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
Bladder volume ultrasound imaging system
Model / Ref / Catalog
BVI 6000 Series, 0270-0791
Primary DI / UDI-DI
10879123004892
510(k) Number
FDA product code
IYO
GMDN term
Bladder volume ultrasound imaging system
Device class
Class II
Regulation number
892.1560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bladder volume ultrasound imaging system

Cleared under the same submission (K022153)

and 4 more cleared under K022153

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)