FDA applicant
Simplex Medical Systems, Inc.
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
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.
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.
See the 510(k) ReportOther applicant names beginning “Simplex”
FDA records each applicant name separately; these may or may not be the same firm.