FDA applicant
Kinetic Concepts, Inc.
FDA records 48 decisions for Kinetic Concepts, Inc. (San Antonio, TX) from 1978 to 2005: 48 510(k) clearances. Most are in product codes FNM (Mattress, Air Flotation, Alternating Pressure) and OMP (Negative Pressure Wound Therapy Powered…). Its devices cite 23 predicates, 18 of them its own earlier devices. 6 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Kinetic Concepts, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Kinetic Concepts, Inc. since 2007.
Recalls per year
1in 2009
Class I Class II/III not classified
Planning a device like Kinetic Concepts, 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 “Kinetic”
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