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ClearTone Doppler CT150-5

by CooperSurgical, Inc.

ClearTone Doppler CT150-5 is a Class II device made by CooperSurgical, Inc., cleared under FDA 510(k) K024197 on 3 Jan 2003 and listed in FDA GUDID since 20 Jul 2016 (UDI-DI 00888937001495), active as of 23 Oct 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) K024197

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00888937001495 UDI-DI Date20 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK024197 Date3 Jan 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K024197 decided 3 Jan 2003 Active
  • FDA GUDID UDI-DI 00888937001495 listed 20 Jul 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1131-2018 FDA Class II initiated 6 Oct 2017 on shared 510(k) K024197

    The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe

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) K024197
  2. Listed FDA GUDID 00888937001495
  3. Recall initiated FDA recalls Z-1131-2018

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ClearTone Doppler
Generic name
Noninvasive vascular ultrasound system
Model / reference
CT150-5
Primary DI / UDI-DI
00888937001495
510(k) Number
FDA product code
HEP
GMDN term
Noninvasive vascular ultrasound system
Device class
Class II
Regulation number
884.2660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Noninvasive vascular ultrasound system

Cleared under the same submission (K024197)

and 8 more cleared under K024197

Similar devices

Other devices filed under FDA product code HEP (Monitor, Blood-Flow, Ultrasonic).

Other devices from CooperSurgical, Inc.

See all devices from CooperSurgical, Inc. →

Properties

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