510(k) Report

FDA applicant

Shenzhen Jiacom Technology CO ., Ltd.

Shenzhen, CN4 decisions2018–20180 recalls

FDA records 4 decisions for Shenzhen Jiacom Technology CO ., Ltd. (Shenzhen, CN) in 2018: 4 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and FLL (Continuous Measurement Thermometer). Since 2016 its 510(k)s took a median of 197 days from receipt to decision, against 222 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 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 Jiacom Technology CO ., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2018

2018: 4
2018high 4 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Shenzhen Jiacom Technology CO ., Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shenzhen Jiacom 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.

See the 510(k) Report

Which product codes does it file in?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions
  • FLLContinuous Measurement Thermometer2decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 197 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 222 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K172874Infrared ThermometerShenzhen Jiacom Technology CO ., Ltd. · 2018
  • K172894Infrared ThermometerShenzhen Jiacom Technology CO ., Ltd. · 2018
  • K172972Wrist Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology CO ., Ltd. · 2018
  • K172896Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A…Shenzhen Jiacom Technology CO ., Ltd. · 2018

All 4 as Shenzhen Jiacom Technology CO ., Ltd. →