BK Medical ApS
HERLEV Hovedstaden, DK
BK MEDICAL APS appears in FDA device records in HERLEV Hovedstaden, DK. FDA records list 27 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to BK Medical ApS carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- B-K Medical Aps510(k), enforcement report, recall
510(k) clearance history
FDA records hold 27 510(k) clearances for BK Medical ApS between 2001 and 2023. The busiest year on record is 2014, with 5. The most recent is 2023, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 3 |
| 2002 | 1 |
| 2003 | 1 |
| 2005 | 2 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2014 | 5 |
| 2015 | 3 |
| 2016 | 1 |
| 2018 | 2 |
| 2022 | 1 |
| 2023 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231764 | Ultrasound System 1300 | IYN | Substantially Equivalent | |
| K223830 | Ultrasound System 2300 | IYN | Substantially Equivalent | |
| K222441 | Ultrasound System 2300 | IYN | Substantially Equivalent | |
| K180737 | Ultrasound Scanner System bk2300 | IYN | Substantially Equivalent | |
| K173569 | Ultrasound System 1300 | IYN | Substantially Equivalent | |
| K161960 | bk2300 | IYN | Substantially Equivalent | |
| K151910 | Ultrasound Scanner System BK2300 | IYN | Substantially Equivalent | |
| K152052 | Ultrasound Scanner System bk2300 | IYN | Substantially Equivalent | |
| K143298 | Ultrasound Scanner System bk2300 | IYN | Substantially Equivalent | |
| K140428 | ULTRASOUND SCANNER SYSTEM BK2300 | IYO | Substantially Equivalent | |
| K132346 | ULTRASOUND SCANNER PRO FOCUS 2202 | IYO | Substantially Equivalent | |
| K132335 | ULTRASOUND SCANNER FLEX FOCUS 1202 | IYN | Substantially Equivalent | |
| K132677 | ULTRASOUND SCANNER FLEX FOCUS 1202 | IYN | Substantially Equivalent | |
| K132685 | ULTRASOUND SCANNER PRO FOCUS 2202 | IYN | Substantially Equivalent | |
| K123254 | ULTRASOUND SCANNER FLEX FOCUS | IYN | Substantially Equivalent | |
| K100919 | PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 | IYN | Substantially Equivalent | |
| K083667 | NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 | ITX | Substantially Equivalent | |
| K081323 | BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 | FCG | Substantially Equivalent | |
| K081154 | ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 | IYO | Substantially Equivalent | |
| K070077 | ULTRASOUND SCANNER PROFOCUS, MODEL 2202 | IYO | Substantially Equivalent | |
| K043554 | ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 | IYN | Substantially Equivalent | |
| K043524 | ULTRASOUND SCANNER PRO FOCUS, MODEL 2202 | IYN | Substantially Equivalent | |
| K024236 | ULTRASOUND SCANNER, TYPE 2400 | IYN | Substantially Equivalent | |
| K023457 | ULTRASOUND SCANNER, TYPE 1101 | IYO | Substantially Equivalent | |
| K011417 | ULTRASOUND SCANNER, TYPE 2102 | IYO | Substantially Equivalent | |
| K003986 | ULTRASOUND SCANNER TYPE 2102 | IYN | Substantially Equivalent | |
| K003041 | ULTRASOUND SCANNER TYPE 2101 | IYO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9680269 | 3003705156 | BK MEDICAL APS | MILEPARKEN 34, HERLEV Hovedstaden DK-2730 DK | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0440-2026 | bk5000 Ultrasound System w/battery; Model No. 2300-61; 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. | Class II | Open, Classified | |
| Z-0439-2026 | bk3500 Ultrasound System w/battery; Model No. 2300-41; 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. | Class II | Open, Classified | |
| Z-0438-2026 | bk3000 Ultrasound System w/battery; Model No. 2300-66; 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. | Class II | Open, Classified | |
| Z-0437-2026 | UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; 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. | Class II | Open, Classified | |
| Z-0436-2026 | Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; 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. | Class II | Open, Classified | |
| Z-0435-2026 | 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. | Class II | Open, Classified | |
| Z-0136-2025 | 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. | Class II | Open, Classified | |
| Z-0813-2024 | 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. | Class II | Open, Classified | |
| Z-2325-2016 | 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 processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN | 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. | Class II | Terminated | |
| Z-0504-2009 | 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 Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2101 and Diagnostic Ultrasound Transducer 8667 Performing ultrasound guided biopsies of the prostate. | No 510k approved | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain