FDA applicant

Suntech Medical, Inc.

Morrisville, NC8 decisions2005–20163 recalls

FDA records 8 decisions for Suntech Medical, Inc. (Morrisville, NC) from 2005 to 2016: 8 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and DXQ (Blood Pressure Cuff). Its devices cite 13 predicates, 3 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Suntech Medical”.

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 Suntech Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2016

2007high 2 (2016) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2020

2007high 2 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Suntech Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Suntech Medical, 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 “Suntech”

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

Suntech Medical Instruments, Inc. 5 Suntech UK, Ltd. 2 Suntech USA, Inc. 1

Suntech Medical, Inc.

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?

Other applicant names beginning “Suntech”