FDA applicant

Data Critical Corp.

Bothell, WA11 decisions1997–20010 recalls

FDA records 11 decisions for Data Critical Corp. (Bothell, WA) from 1997 to 2001: 11 510(k) clearances. Most are in product codes MSX (System, Network And Communication…) and DPS (Electrocardiograph). Its devices cite 11 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Data Critical Corporation”.

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 Data Critical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Data Critical Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Data Critical Corp.’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 “Data”

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

Data Medical Associates, Inc. 111 Data Sciences Intl., Inc. 1 Data Ray 1

Data Critical Corp.

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?

Other applicant names beginning “Data”