Ust-5550

by Fujifilm Corporation

Ust-5550 is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K140443 on 16 Jun 2014 (5 earlier submissions) and listed in FDA GUDID since 17 Jul 2021 (UDI-DI 04573596212936), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 closed

Documents

+5 more

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04573596212936 UDI-DI	Date17 Jul 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK140443	Date16 Jun 2014Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK134016	Date28 Mar 2014Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK122537	Date12 Apr 2013Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK122341	Date26 Sep 2012Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK093488	Date20 Nov 2009Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK043196	Date30 Nov 2004Decided	StatusActive

Official records

AccessGUDID record UDI-DI 04573596212936
FDA 510(k) database 510(k) number K140443
FDA 510(k) database 510(k) number K134016
FDA 510(k) database 510(k) number K122537
FDA 510(k) database 510(k) number K122341
FDA 510(k) database 510(k) number K093488
FDA 510(k) database 510(k) number K043196

Across registries

2 registries list this device

FDA 510(k) K140443 decided 16 Jun 2014 Active· +5 more in the status table
FDA GUDID UDI-DI 04573596212936 listed 17 Jul 2021 Listed

Recalls

2 recalls · FDA

- Terminated Z-1341-2020 FDA Class II initiated 31 Jan 2020
These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.
- Terminated Z-2090-2017 FDA Class II initiated 2 May 2017
The strength of the arm mounting mechanism was insufficient and had to be redesigned.

Timeline

9 dated events

30 Nov 2004 Cleared FDA 510(k) K043196
20 Nov 2009 Cleared FDA 510(k) K093488
26 Sep 2012 Cleared FDA 510(k) K122341
12 Apr 2013 Cleared FDA 510(k) K122537
28 Mar 2014 Cleared FDA 510(k) K134016
16 Jun 2014 Cleared FDA 510(k) K140443
2 May 2017 Recall initiated FDA recalls Z-2090-2017
31 Jan 2020 Recall initiated FDA recalls Z-1341-2020
17 Jul 2021 Listed FDA GUDID 04573596212936

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Surgical ultrasound imaging transducer
Model / reference: UST-5550

Primary DI / UDI-DI: 04573596212936
FDA product code: IYO, IYN, ITX
GMDN term: Surgical ultrasound imaging transducer

Device class: Class II
Regulation number: 892.1560, 892.1550, 892.1570
GUDID distribution status: In Commercial Distribution

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Properties

Sterilise before use
Prescription use
Serial number
Manufacturing date

Other properties (11, all answered No)