# DEN150010: Dignitana AB DigniCap System

- Pathway: De Novo (Direct)
- Applicant: Dignitana AB
- Decided: Dec 8, 2015 after 277 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K170871: DigniCap Scalp Cooling System (2017), 2 descendants of its own
- K163484: Paxman Scalp Cooler (2017), 2 descendants of its own
- K191166: DigniCap Delta (2019), 1 descendant of its own
- K173032: Paxman Scalp Cooler (2018), 1 descendant of its own
- K252289: Eva Scalp Cooling System (2025), 0 descendants of its own

## Indications for use
indicated to reduce the likelihood of chemotherapy-induced alopecia in women with breast cancer

Source page: https://510kreport.com/device/DEN150010
Methodology: https://510kreport.com/methodology