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Transonic ADT1010-40

by Transonic Systems Inc. 2 variants

Transonic ADT1010-40 is a Class II device made by Transonic Systems Inc., cleared under FDA 510(k) K021571 on 12 Aug 2002 and listed in FDA GUDID since 1 Oct 2020 (UDI-DI 00877466000468), 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) K021571

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 Number00877466000468 UDI-DI Date1 Oct 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK021571 Date12 Aug 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K021571 decided 12 Aug 2002 Active
  • FDA GUDID UDI-DI 00877466000468 listed 1 Oct 2020 Listed

Recalls

1 recall · FDA

    • Terminated Z-1776-2018 FDA Class II initiated 15 Feb 2018 on shared 510(k) K021571

    The sterility of the device cannot be assured. There is a potential for an increased risk of infection.

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) K021571
  2. Recall initiated FDA recalls Z-1776-2018
  3. Listed FDA GUDID 00877466000468

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Transonic
Generic name
Noninvasive vascular ultrasound system, line-powered
Model / reference
ADT1010-40
Primary DI / UDI-DI
00877466000468
510(k) Number
FDA product code
MQS
GMDN term
Noninvasive vascular ultrasound system, line-powered
Device class
Class II
Regulation number
876.5820
GUDID distribution status
In Commercial Distribution

Related devices

Category: Noninvasive vascular ultrasound system, line-powered

Similar devices

Other devices filed under FDA product code MQS (System, Hemodialysis, Access Recirculation Monitoring).

Other devices from Transonic Systems Inc.

  • Transonic HQC1.5FMC

    Class II

  • Transonic HQC4FMV

    Class II

  • Transonic HQC3FMC

    Class II

  • Transonic HQC2MP

    Class II

See all devices from Transonic Systems Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)