# K173032: Paxman Scalp Cooler

- Pathway: 510(k) (Traditional)
- Applicant: Paxman Coolers Limited
- Decided: Jun 7, 2018 after 252 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: 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)
- K163484: Paxman Scalp Cooler, Paxman Coolers Limited (2017) Summary page 5.

## Most influential descendants
- K211526: Portable Scalp Cooling System (2021), 0 descendants of its own

## Indications for use
The Paxman Scalp Cooler is indicated to reduce the likelihood of chemotherapy-induced alopecia (CIA) in cancer patients with solid tumors.

Source page: https://510kreport.com/device/K173032
Methodology: https://510kreport.com/methodology