510(k) Report

FDA applicant

Em-Scan, Inc.

Washington, DC1 decision1990–19900 recalls

FDA records 1 decision for Em-Scan, Inc. (Washington, DC) in 1990: 1 510(k) clearance. All are in product code DSB (Plethysmograph, Impedance). 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 Em-Scan, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Em-Scan, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Em-Scan, 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

Which product codes does it file in?

  • DSBPlethysmograph, Impedance1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K902042EM-Scan HP-2 Pediatric Body Composition AnalyzerEm-Scan, Inc. · 19901cites it

What has FDA decided for it lately?

  • K902042EM-Scan HP-2 Pediatric Body Composition AnalyzerEm-Scan, Inc. · 1990

The one decision as Em-Scan, Inc. →