510(k) Report

FDA applicant

Pulse Scientific, Inc.

Burlington, Ont., Canada, CA3 decisions1992–19920 recalls

FDA records 3 decisions for Pulse Scientific, Inc. (Burlington, Ont., Canada, CA) in 1992: 3 510(k) clearances. Most are in product codes KTN (System, Test, Infectious Mononucleosis) and DHR (System, Test, Rheumatoid Factor). 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Pulse Scientific, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Pulse Scientific, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Pulse”

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