# K162365: T-Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Terumobct, Inc.
- Decided: Feb 16, 2017 after 177 days
- Product code: KCY (Tourniquet, Pneumatic)
- Device class: 1
- Regulation: 21 CFR 878.5910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K875092 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112874: EZ Vein Inflatable Tourniquet, Dominion Medical Devices, LLC (2011) Summary page 4.

## Indications for use
T-Cuff is indicated for use in donor populations during apheresis procedures as an alternative method to maintain pressure on the arm and obtain venipuncture. The T-Cuff operates similar to a pneumatic tourniquet intended to partially restrict blood flow on the upper arm to result in optimal venous access during apheresis collection procedures.

Source page: https://510kreport.com/device/K162365
Methodology: https://510kreport.com/methodology