510(k) Report

FDA applicant

Healcerion Co., Ltd.

Seoul, KR4 decisions2015–20220 recalls

FDA records 4 decisions for Healcerion Co., Ltd. (Seoul, KR) from 2015 to 2022: 4 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Since 2016 its 510(k)s took a median of 275 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 3 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 Healcerion Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2015: 12017: 12022: 2
2015high 2 (2022) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

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

Planning a device like Healcerion Co., Ltd.’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
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 275 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 105 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 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.

  • K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 20155cite it
  • K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd. · 20173cite it

What has FDA decided for it lately?

  • K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd. · 2022
  • K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd. · 2022
  • K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd. · 2017
  • K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 2015

All 4 as Healcerion Co., Ltd. →