Data / Medical devices / Denmark / BK Medical Aps

BK Medical Aps: FDA-registered device maker in HERLEV Hovedstaden, Denmark, 7 510(k) clearances

Name: BK Medical Aps FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

BK Medical Aps is registered with the FDA (registration 9680269) in HERLEV Hovedstaden, Denmark. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated October 23, 2023. 5 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 9680269
FEI number: 3003705156
Address: Mileparken 34, HERLEV Hovedstaden, Denmark, DK-2730
Owner or operator: GE HealthCare Technologies Inc. (9912004)
Roles: Manufacturer, Specification developer
First device listed: October 6, 2023
Registered through: 2027
Brand names listed: 1202 (Flex Focus), 1300 (bkSpecto), 13L4w, 14L3, 14L3e, 18L5, 18L5s, 2052 and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Manufacturer, Specification developer	accessdata.fda.gov
Biopsy Needle	FCG	2	Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer, Specification developer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 23, 2023	K231764	Ultrasound System 1300	IYN	Substantially Equivalent	Bk Medical Aps	accessdata.fda.gov
April 11, 2023	K223830	Ultrasound System 2300	IYN	Substantially Equivalent	Bk Medical Aps	accessdata.fda.gov
August 1, 2018	K180737	Ultrasound Scanner System bk2300	IYN	Substantially Equivalent	Bk Medical Aps	accessdata.fda.gov
February 23, 2018	K173569	Ultrasound System 1300	IYN	Substantially Equivalent	Bk Medical Aps	accessdata.fda.gov
January 10, 2014	K132335	ULTRASOUND SCANNER FLEX FOCUS 1202	IYN	Substantially Equivalent	B-K Medical Aps	accessdata.fda.gov
February 2, 2009	K083667	NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337	ITX	Substantially Equivalent	B-K Medical Aps	accessdata.fda.gov
July 22, 2008	K081323	BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818	FCG	Substantially Equivalent	B-K Medical Aps	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 9, 2025	97830	Class II	Ongoing	1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic	GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.	accessdata.fda.gov
September 4, 2024	95431	Class II	Ongoing	bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.	The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inoperable.	accessdata.fda.gov
November 30, 2023	93598	Class II	Ongoing	bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.	An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.	accessdata.fda.gov
June 28, 2016	74691	Class II	Terminated	BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data pro	In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be unaware of the calculation factor (1) and assume the generic volume calculation factor is similar to that of the other (prostate, adenoma, testis, kidney, and bladder) volume calculation factors provided in the software.	accessdata.fda.gov
September 8, 2008	50157	Not yet classified	Terminated	Single-use sterile puncture attachment UA1256-U used with the BK Medical Ultrasounds: Diagnostic Ultrasound scanner Pro Focus 2202 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2102 and Diagnost	No 510k approved	accessdata.fda.gov

Compare with other makers

Updated November 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.