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B-K Medical A/S

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
7
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0437-2026Class IIUUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, UltrOctober 9, 2025
Z-0440-2026Class IIbk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, UltrasonicOctober 9, 2025
Z-0439-2026Class IIbk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, UltrasonicOctober 9, 2025
Z-0436-2026Class IIUltrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed DoOctober 9, 2025
Z-0435-2026Class II1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex October 9, 2025
Z-0438-2026Class IIbk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, UltrasonicOctober 9, 2025
Z-0136-2025Class IIbk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #23September 4, 2024
Z-0813-2024Class IIbkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.November 30, 2023
Z-2325-2016Class IIBK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2June 28, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K043554ULTRASOUND SCANNER MINI FOCUS, MODEL 1402January 14, 2005
K043524ULTRASOUND SCANNER PRO FOCUS, MODEL 2202January 13, 2005
K024236ULTRASOUND SCANNER, TYPE 2400January 17, 2003
K023457ULTRASOUND SCANNER, TYPE 1101November 1, 2002
K011417ULTRASOUND SCANNER, TYPE 2102June 8, 2001
K003986ULTRASOUND SCANNER TYPE 2102April 3, 2001
K003041ULTRASOUND SCANNER TYPE 2101February 7, 2001