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Verathon Inc. Bladderscan Bvm 9500 Ultrasound

by Verathon Incorporated

510(k) K090214

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK090214 Date13 Mar 2009ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0005-2011 FDA Unclassified (pre-2012) initiated 23 Aug 2010

    The BladderScan BVM 9500 devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IYO
Device Class
Class II
Regulation
21 CFR Part 892.1560
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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