FDA applicant
Span-America Medical Systems, Inc.
FDA records 19 decisions for Span-America Medical Systems, Inc. (Greenville, SC) from 1980 to 1998: 19 510(k) clearances. Most are in product codes FNM (Mattress, Air Flotation, Alternating Pressure) and KMJ (Lubricant, Patient). Its devices cite 6 predicates, 6 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
How often FDA has decided Span-America Medical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Span-America Medical Systems, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Span-America 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) Report