510(k) Report

FDA applicant

Bk Medical Aps

Herlev, DK9 decisions2015–20238 recalls

FDA records 9 decisions for Bk Medical Aps (Herlev, DK) from 2015 to 2023: 9 510(k) clearances. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Since 2016 its 510(k)s took a median of 114 days from receipt to decision, against 95 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 7 of them its own earlier devices. 8 recalls are linked to its devices.

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

FDA decisions per year

2in 2023

2015: 32016: 12018: 22022: 12023: 2
2015high 3 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

5in 2025

2016: 12023: 12024: 12025: 5
2015high 5 (2025) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Bk Medical Aps by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic9decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 114 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 95 days; 1 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 7 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K161960bk2300Bk Medical Aps · 20162cite it
  • K222441Ultrasound System 2300Bk Medical Aps · 20221cites it
  • K173569Ultrasound System 1300Bk Medical Aps · 20181cites it
  • K180737Ultrasound Scanner System bk2300Bk Medical Aps · 20181cites it
  • K143298Ultrasound Scanner System bk2300Bk Medical Aps · 20151cites it
  • K151910Ultrasound Scanner System BK2300Bk Medical Aps · 20151cites it

What has FDA decided for it lately?

  • K231764Ultrasound System 1300Bk Medical Aps · 20231 recall
  • K223830Ultrasound System 2300Bk Medical Aps · 20236 recalls
  • K222441Ultrasound System 2300Bk Medical Aps · 2022
  • K180737Ultrasound Scanner System bk2300Bk Medical Aps · 2018
  • K173569Ultrasound System 1300Bk Medical Aps · 2018
  • K161960bk2300Bk Medical Aps · 2016
  • K151910Ultrasound Scanner System BK2300Bk Medical Aps · 20151 recall
  • K152052Ultrasound Scanner System bk2300Bk Medical Aps · 20151 recall

All 9 as Bk Medical Aps →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K223830bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler…Oct 9, 2025Class II
  • K223830bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler…Oct 9, 2025Class II
  • K223830bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler…Oct 9, 2025Class II
  • K231764Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System…Oct 9, 2025Class II
  • K223830UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed…Oct 9, 2025Class II
  • K223830bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive…Sep 4, 2024Class II