# K150813: iTClamp50

- Pathway: 510(k) (Special)
- Applicant: Innovative Trauma Care, Inc.
- Decided: Apr 30, 2015 after 34 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K890443 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140805: Itclamp 50, Innovative Trauma Care, Inc. (2014) Summary page 4.

## Indications for use
The iTClamp®50 is a trauma clamp device for the temporary control of severe bleeding in the extremities, axilla, inguinal areas, scalp, and neck.

Source page: https://510kreport.com/device/K150813
Methodology: https://510kreport.com/methodology