FDA applicant
Sound 2000 Medical Systems, Inc.
FDA records 1 decision for Sound 2000 Medical Systems, Inc. (Edina, MN) in 1991: 1 510(k) clearance. All are in product code KZE (Injector, Fluid, Non-Electrically Powered). 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 Sound 2000 Medical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Sound 2000 Medical Systems, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Sound 2000 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 “Sound”
FDA records each applicant name separately; these may or may not be the same firm.