# K252289: Eva Scalp Cooling System

- Pathway: 510(k) (Traditional)
- Applicant: Stemtech Medical Devices Private Limited
- Decided: Nov 25, 2025 after 125 days
- Product code: PMC (Scalp Cooling System)
- Device class: 2
- Regulation: 21 CFR 878.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN150010 (2015). 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)
- K191166: DigniCap Delta, Dignitana, Inc. (2019) Summary page 6.

## Indications for use
The Eva Scalp Cooling System is indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors.

Source page: https://510kreport.com/device/K252289
Methodology: https://510kreport.com/methodology