S31KP: CE/MDD Class IIa, Fujifilm Corporation

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-04573596212301 Basic UDI-DI 04573596212301UDI-DI	Date30 Oct 2026Registered	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated	NumberK220295	Date29 Apr 2022Decided	StatusActive
United States	GUDID listing GUDID	Number04573596212301 UDI-DI	Date18 Jul 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK202422	Date4 Nov 2020Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK191233	Date9 Aug 2019Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK163505	Date30 May 2017Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK160559	Date18 Oct 2016Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK140443	Date16 Jun 2014Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK134016	Date28 Mar 2014Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-04573596212301 — open Devices and search for it
AccessGUDID record UDI-DI 04573596212301
FDA 510(k) database 510(k) number K220295
FDA 510(k) database 510(k) number K202422
FDA 510(k) database 510(k) number K191233
FDA 510(k) database 510(k) number K163505
FDA 510(k) database 510(k) number K160559
FDA 510(k) database 510(k) number K140443
FDA 510(k) database 510(k) number K134016

Across registries

3 registries list this device

EUDAMED Basic UDI-DI B-04573596212301 registered 30 Oct 2026 Active
FDA 510(k) K220295 decided 29 Apr 2022 Active· +6 more in the status table
FDA GUDID UDI-DI 04573596212301 listed 18 Jul 2021 Listed

Recalls

4 recalls · 2 ongoing · FDA

- Ongoing Z-1884-2024 FDA Class II initiated 11 Apr 2024
AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).
- Ongoing Z-0189-2022 FDA Class II initiated 14 Oct 2021
Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.
- 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

13 dated events

2 May 2017 Recall initiated FDA recalls Z-2090-2017
30 May 2017 Cleared FDA 510(k) K163505
9 Aug 2019 Cleared FDA 510(k) K191233
31 Jan 2020 Recall initiated FDA recalls Z-1341-2020
4 Nov 2020 Cleared FDA 510(k) K202422
18 Jul 2021 Listed FDA GUDID 04573596212301
14 Oct 2021 Recall initiated FDA recalls Z-0189-2022
29 Apr 2022 Cleared FDA 510(k) K220295
11 Apr 2024 Recall initiated FDA recalls Z-1884-2024
30 Oct 2026 Registered EUDAMED B-04573596212301

3 earlier events are in the sections above.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: S31KP Probe EUDAMED
S31KP GUDID
Generic name: Surgical ultrasound imaging transducer
Model / reference: S31KP, 04573596212301

Primary DI / UDI-DI: 04573596212301
Basic UDI-DI: B-04573596212301
510(k) Number: K134016
K140443
K160559
K163505
K191233
K202422
K220295
FDA product code: IYO, IYN, ITX
EMDN code: Z11040299 Ultrasound probes – other
GMDN term: Surgical ultrasound imaging transducer

Device class: Class IIa EUDAMED
Class II GUDID
Regulation number: 892.1560, 892.1550, 892.1570
EU registration type: Legacy device (under a directive)
EU market of registration: Netherlands
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED Class IIa	GUDID Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Category: Surgical ultrasound imaging transducer

Cleared under the same submission (K134016)

and 5 more cleared under K134016

Cleared under the same submission (K140443)

and 2 more cleared under K140443

Similar devices

Also classified as Surgical ultrasound imaging transducer.

HUMANSCAN 5491310 — Humanscan Company, Ltd. Class II
I13C3f Transducer 9076 — Bk Medical ApS Class II
7LT4 Ultrasonic Transducer(FDA) PL1H-30-91142 — Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Class II
HUMANSCAN 5721640 — Humanscan Company, Ltd. Class II
C9150LA — FUJIFILM Healthcare Americas Corporation Class II

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Properties

Sterilise before use
Prescription use
Serial number
Manufacturing date

Other properties (19, all answered No)