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Bbs Revolution

by Dbmedx, Inc.

510(k) K142329

Bbs Revolution is a medical device (FDA Class II; FDA product code IYO, System, Imaging, Pulsed Echo, Ultrasonic) made by Dbmedx, Inc., cleared under FDA 510(k) K142329 on 15 Dec 2014, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK142329 Date15 Dec 2014ClearedStatusActive

Official records

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  • Withdrawn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

Devices cleared under K142329

3 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K142329
UDI-DISize and differences
Attendant® Prodigy™ Bladder Scanner PD-010-0007
Dbmedx, Inc.
PD-010-0007 / PD-010-000700869209000231 —No longer on the market
Attendant® Prodigy™ Bladder Scanner PD-010-0010
Dbmedx, Inc.
PD-010-0010 / PD-010-001000860001971439 —On the market
BBS Revolution™ PD-010-0002
Dbmedx, Inc.
PD-010-0002 / PD-010-000200869209000200 —On the market

Similar devices

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

Other devices from Dbmedx, Inc.