510(k) Report

FDA applicant

B-K Medical Aps

Herlev, DK15 decisions1981–20142 recalls

FDA records 15 decisions for B-K Medical Aps (Herlev, DK) from 1981 to 2014: 15 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 17 predicates, 5 of them its own earlier devices. 2 recalls are linked to its devices.

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

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 Aps’s devices, and how often a recall has named them.

FDA decisions per year

5in 2014

2007: 12008: 22009: 12011: 12013: 12014: 5
2007high 5 (2014) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2025

2016: 12025: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like B-K Medical Aps’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, Ultrasonic5decisions
  • ITXTransducer, Ultrasonic, Diagnostic1decision
  • FCGBiopsy Needle1decision
  • KODCatheter, Urological1decision

Whose devices does it build on?

Its devices cite 17 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 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.

  • K100919Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202B-K Medical Aps · 20115cite it
  • K081154Ultrasound Scanner Flex Focus, Model 1202B-K Medical Aps · 20084cite it
  • K140428Ultrasound Scanner System BK2300B-K Medical Aps · 20142cite it
  • K943315Ultrasound Scanner 2002B&K Medical · 19962cite it
  • K123254Ultrasound Scanner Flex FocusB-K Medical Aps · 20132cite it
  • K083667Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model UA 1336, Needle Guide for 8824, Model UA…B-K Medical Aps · 20091cites it

What has FDA decided for it lately?

  • K140428Ultrasound Scanner System BK2300B-K Medical Aps · 20141 recall
  • K132335Ultrasound Scanner Flex Focus 1202B-K Medical Aps · 20141 recall
  • K132346Ultrasound Scanner Pro Focus 2202B-K Medical Aps · 2014
  • K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps · 2014
  • K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps · 2014
  • K123254Ultrasound Scanner Flex FocusB-K Medical Aps · 2013
  • K100919Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202B-K Medical Aps · 2011
  • K083667Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model UA 1336, Needle Guide for 8824, Model UA…B-K Medical Aps · 2009

All 11 as B-K Medical Aps →All 4 as B&K Medical →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K1323351202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus…Oct 9, 2025Class II
  • K140428BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases…Jun 28, 2016Class II