510(k) Report

FDA applicant

Octostop, Inc.

Montreal, Qc., CA13 decisions1991–19970 recalls

FDA records 13 decisions for Octostop, Inc. (Montreal, Qc., CA) from 1991 to 1997: 13 510(k) clearances. Most are in product codes KPR (System, X-Ray, Stationary) and KXH (Cradle, Patient, Radiologic). Its devices cite 1 predicate, 1 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Octostop, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Octostop, 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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