510(k) Report

FDA applicant

Shenzhen Changkun Technology Co., Ltd.

Shenzhen, CN7 decisions2020–20260 recalls

FDA records 7 decisions for Shenzhen Changkun Technology Co., Ltd. (Shenzhen, CN) from 2020 to 2026: 7 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and HGX (Pump, Breast, Powered). Since 2016 its 510(k)s took a median of 317 days from receipt to decision, against 190 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 1 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, cardiovascular panel, where it files most

How often FDA has decided Shenzhen Changkun Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2020: 12021: 22023: 22026 (partial year): 2
2020high 2 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Shenzhen Changkun Technology Co., Ltd. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shenzhen Changkun Technology 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?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions
  • HGXPump, Breast, Powered2decisions
  • DQAOximeter1decision
  • FLLContinuous Measurement Thermometer1decision
  • KPIStimulator, Electrical, Non-Implantable, For Incontinence1decision

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 317 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 190 days; 1 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K193253Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503Shenzhen Changkun Technology Co., Ltd. · 20204cite it
  • K231595Electric Breast PumpShenzhen Changkun Technology Co., Ltd. · 20231cites it

What has FDA decided for it lately?

  • K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)Shenzhen Changkun Technology Co., Ltd. · 2026
  • K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd. · 2026
  • K231595Electric Breast PumpShenzhen Changkun Technology Co., Ltd. · 2023
  • K221798Finger Pulse Oximeter, Model: X1906PShenzhen Changkun Technology Co., Ltd. · 2023
  • K193387Arm Electronic SphygmomanometerShenzhen Changkun Technology Co., Ltd. · 2021
  • K193386Wrist Electronic SphygmomanometerShenzhen Changkun Technology Co., Ltd. · 2021
  • K193253Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503Shenzhen Changkun Technology Co., Ltd. · 2020

All 7 as Shenzhen Changkun Technology Co., Ltd. →