510(k) Report

FDA applicant

Simplex Medical Systems, Inc.

Las Vegas, NV3 decisions1991–19970 recalls

FDA records 3 decisions for Simplex Medical Systems, Inc. (Las Vegas, NV) from 1991 to 1997: 3 510(k) clearances. Most are in product codes CAI (Circuit, Breathing (W Connector, Adaptor, Y…) and KOJ (Airbrush). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Simplex Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Simplex Medical Systems, 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 “Simplex”

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