510(k) Report

FDA applicant

Orich Medical Equipment (Tianjin) Co., Ltd.

Tianjin Economic Technological Developme, CN2 decisions2012–20160 recalls

FDA records 2 decisions for Orich Medical Equipment (Tianjin) Co., Ltd. (Tianjin Economic Technological Developme, CN) from 2012 to 2016: 2 510(k) clearances. All are in product code KPR (System, X-Ray, Stationary). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Orich Medical Equipment (Tianjin Co., Ltd.”.

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 Orich Medical Equipment (Tianjin) Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2012: 12016: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Orich Medical Equipment (Tianjin) Co., Ltd. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Orich Medical Equipment (Tianjin) Co.…’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