# K952038: Clean-Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Instrumed, Inc.
- Decided: Jul 11, 1995 after 71 days
- Product code: KCY (Tourniquet, Pneumatic)
- Device class: 1
- Regulation: 21 CFR 878.5910
- Recalls of this device: 1 (0 Class I)
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Aug 25, 2011 · Not classified · Z-3274-2011: Three complaints have been reported indicating that the product inside the package did not match the label description. The units had quick connectors instead of luer lock connectors as stated in the 

Source page: https://510kreport.com/device/K952038
Methodology: https://510kreport.com/methodology