# K191166: DigniCap Delta

- Pathway: 510(k) (Traditional)
- Applicant: Dignitana, Inc.
- Decided: Jun 26, 2019 after 56 days
- Product code: PMC (Scalp Cooling System)
- Device class: 2
- Regulation: 21 CFR 878.4360
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN150010 (2015). 2 ancestors in all.
1 later device descends 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)
- K170871: DigniCap Scalp Cooling System, Dignitana AB (2017) Summary page 5.

## Most influential descendants
- K252289: Eva Scalp Cooling System (2025), 0 descendants of its own

## Recalls of this device
- Nov 5, 2021 · Class II · Z-0825-2022: Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patients and instructions for the application of the headband. Additionally, IFU updated to include warnings

## Indications for use
The DigniCap Delta® 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/K191166
Methodology: https://510kreport.com/methodology