FDA applicant

Dws, Inc.

Mchenry, IL3 decisions1976–20240 recalls

FDA records 3 decisions for Dws, Inc. (Mchenry, IL) from 1976 to 2024: 3 510(k) clearances. Most are in product codes FIR (Pump, Blood, Extra-Luminal) and KOC (Accessories, Blood Circuit, Hemodialysis). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Dws S.R.L.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2024

2007high 1 (2024) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dws, 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

Dws, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?