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Clinical Guard Sonoline B

by Clinical Guard

Clinical Guard Sonoline B is a Class II device made by Clinical Guard, cleared under FDA 510(k) K082480 on 25 Feb 2009 and listed in FDA GUDID since 30 Mar 2017 (UDI-DI 00897429002513), active as of 22 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 found

in data synced 22 Oct 2026

Documents

510(k) K082480

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00897429002513 UDI-DI Date30 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK082480 Date25 Feb 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K082480 decided 25 Feb 2009 Active
  • FDA GUDID UDI-DI 00897429002513 listed 30 Mar 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K082480
  2. Listed FDA GUDID 00897429002513

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Clinical Guard
Generic name
Foetal Doppler system probe
Model / reference
Sonoline B
Primary DI / UDI-DI
00897429002513
510(k) Number
FDA product code
KNG
GMDN term
Foetal Doppler system probe
Device class
Class II
Regulation number
884.2660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Foetal Doppler systemFoetal Doppler system probe

Cleared under the same submission (K082480)

and 8 more cleared under K082480

Other devices from Clinical Guard

See all devices from Clinical Guard →

Properties

  • Prescription use
  • Convenience kit
  • Serial number
Other properties (12, all answered No)