FDA applicant

Accumed Healthcare (Shanghai), Inc.

Maple Valley, WA2 decisions2011–20110 recalls

FDA records 2 decisions for Accumed Healthcare (Shanghai), Inc. (Maple Valley, WA) in 2011: 2 510(k) clearances. All are in product code DXN (System, Measurement, Blood-Pressure…). Its devices cite 3 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 Accumed Healthcare (Shanghai), Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2011high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Accumed Healthcare (Shanghai), Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Accumed Healthcare (Shanghai), 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 “Accumed”

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

Accumed Intl., Inc. 12 Accumed Systems, Inc. 1

Accumed Healthcare (Shanghai), 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 “Accumed”