510(k) Report

FDA applicant

B-K Medical A/S

Dk 2820 Gentofte, DK11 decisions1995–20052 recalls

FDA records 11 decisions for B-K Medical A/S (Dk 2820 Gentofte, DK) from 1995 to 2005: 11 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 7 predicates, 5 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “B & K Medical A/S”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided B-K Medical A/S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for B-K Medical A/S since 2007.

Recalls per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — B-K Medical A/S by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like B-K Medical A/S’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic7decisions
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic4decisions

Whose devices does it build on?

Its devices cite 7 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K043524Ultrasound Scanner Pro Focus, Model 2202B-K Medical A/S · 20055cite it
  • K024236Ultrasound Scanner, Type 2400B-K Medical A/S · 20033cite it
  • K936024Ultrasound Scanner 2001B & K Medical A/S · 19951cites it
  • K000567Ultrasound Scanner Type 2102B & K Medical A/S · 20001cites it
  • K011417Ultrasound Scanner, Type 2102B-K Medical A/S · 20011cites it
  • K003986Ultrasound Scanner Type 2102B-K Medical A/S · 20011cites it

What has FDA decided for it lately?

  • K043554Ultrasound Scanner Mini Focus, Model 1402B-K Medical A/S · 2005
  • K043524Ultrasound Scanner Pro Focus, Model 2202B-K Medical A/S · 20051 recall
  • K024236Ultrasound Scanner, Type 2400B-K Medical A/S · 20032 recalls
  • K023457Ultrasound Scanner, Type 1101B-K Medical A/S · 2002
  • K011417Ultrasound Scanner, Type 2102B-K Medical A/S · 2001
  • K003986Ultrasound Scanner Type 2102B-K Medical A/S · 2001
  • K003041Ultrasound Scanner Type 2101B-K Medical A/S · 2001
  • K002085Ultrasound Scanner, Type 1101B & K Medical A/S · 2000

All 7 as B-K Medical A/S →All 4 as B & K Medical A/S →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K024236B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K…Jan 24, 2008
  • K024236Linear Array Transducer Type: 8809Nov 12, 2004