510(k) Report

FDA applicant

Beijing Konted Medical Technology Co.,Ltd

Beijing, CN3 decisions2023–20260 recalls

FDA records 3 decisions for Beijing Konted Medical Technology Co.,Ltd (Beijing, CN) from 2023 to 2026: 3 510(k) clearances. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Since 2016 its 510(k)s took a median of 113 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is 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 Beijing Konted Medical Technology Co.,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2023: 12024: 12026 (partial year): 1
2023high 1 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Beijing Konted Medical Technology Co.,Ltd by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 113 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 115 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 2 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.

  • K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd · 20231cites it
  • K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd · 20241cites it

What has FDA decided for it lately?

  • K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd · 2026
  • K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd · 2024
  • K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd · 2023

All 3 as Beijing Konted Medical Technology Co.,Ltd →