FDA applicant

K-Jump Health Co., Ltd.

Taipei Hsien, TW26 decisions1990–20181 recall

FDA records 26 decisions for K-Jump Health Co., Ltd. (Taipei Hsien, TW) from 1990 to 2018: 26 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and DXN (System, Measurement, Blood-Pressure…). Its devices cite 15 predicates, 5 of them its own earlier devices. 1 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, general hospital panel, where it files most

How often FDA has decided K-Jump Health Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2007high 3 (2009) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2015

2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — K-Jump Health Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like K-Jump Health 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

K-Jump Health Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?