FDA applicant

Icare Newlife Technologies, Inc.

Beijing, CN1 decision2015–20150 recalls

FDA records 1 decision for Icare Newlife Technologies, Inc. (Beijing, CN) in 2015: 1 510(k) clearance. All are in product code HEK (Monitor, Heart Sound, Fetal, Ultrasonic). Its devices cite 1 predicate, 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Icare Newlife Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Icare Newlife Technologies, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Icare Newlife Technologies, Inc.’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

Other applicant names beginning “Icare”

FDA records each applicant name separately; these may or may not be the same firm.

Icare Finland OY 7

Icare Newlife Technologies, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Icare”