# K170871: DigniCap Scalp Cooling System

- Pathway: 510(k) (Traditional)
- Applicant: Dignitana AB
- Decided: Jul 3, 2017 after 102 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: 1 generation back to DEN150010 (2015). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN150010: Dignitana AB DigniCap System, Dignitana AB (2015) Summary page 4.

## Most influential descendants
- K191166: DigniCap Delta (2019), 1 descendant of its own
- K252289: Eva Scalp Cooling System (2025), 0 descendants of its own

## Indications for use
The DigniCap® 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/K170871
Methodology: https://510kreport.com/methodology