Clearvue 350/550 Diagnostic Ultrasound System

510(k) K120321

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK120321	Date17 Feb 2012Cleared	StatusActive

8 recalls · 7 ongoing · FDA

5 recalls, same reason
- Ongoing Z-1625-2026 FDA Class III initiated 5 Sep 2025 on shared 510(k) K120321
- Ongoing Z-2364-2025 FDA Class III initiated 3 Jul 2025
- Ongoing Z-2353-2025 FDA Class III initiated 3 Jul 2025
- Ongoing Z-2373-2025 FDA Class III initiated 3 Jul 2025
- Ongoing Z-2391-2025 FDA Class III initiated 3 Jul 2025
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2 recalls, same reason
- Ongoing Z-2050-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K120321
- Ongoing Z-2055-2025 FDA Class II initiated 28 May 2025 on shared 510(k) K120321
Ultrasound transducer devices were refurbished beyond their useful life.
- Completed Z-2517-2023 FDA Class II initiated 30 Jun 2023 on shared 510(k) K120321
Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in safety measures to prevent electric were to also fail.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)