# K961854: SPR Plus II Overlay System (CL250/CL212

- Pathway: 510(k) (Traditional)
- Applicant: Gaymar Industries, Inc.
- Decided: Aug 9, 1996 after 87 days
- Product code: FNM (Mattress, Air Flotation, Alternating Pressure)
- Device class: 2
- Regulation: 21 CFR 880.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CLA 1500 System: named in the summary without a submission number

## Indications for use
The SPR+II overlay system is a pressure relieving support system intended to reduce the potential for development of pressure ulcers on at risk patients or to be used in the treatment of existing pressure ulcers.

Source page: https://510kreport.com/device/K961854
Methodology: https://510kreport.com/methodology