FDA applicant

Spectral Medical, Inc.

Toronto, CA2 decisions2017–20190 recalls

FDA records 2 decisions for Spectral Medical, Inc. (Toronto, CA) from 2017 to 2019: 2 510(k) clearances. Most are in product codes NGS (Assay, Endotoxin Activity, Chemiluminescent) and KDI (Dialyzer, High Permeability With Or Without…). Its devices cite 1 predicate, 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, microbiology panel, where it files most

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

FDA decisions per year

1in 2019

2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Spectral Medical, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Spectral 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 “Spectral”

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

Spectral Diagnostics, Inc. 12 Spectral Data Systems 2 Spectral Visualization & Development, Inc. 1

Spectral Medical, 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 “Spectral”