# PMC: Scalp Cooling System

- Device class: 2; regulation: 21 CFR 878.4360; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 141 days (middle half 133–149)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2015: 1
- 2017: 2
- 2018: 1
- 2019: 1
- 2021: 1
- 2025: 1

## Most-cited predicates
- DEN150010: Dignitana AB DigniCap System (2015), cited by 2
- K191166: DigniCap Delta (2019), cited by 1
- K173032: Paxman Scalp Cooler (2018), cited by 1
- K163484: Paxman Scalp Cooler (2017), cited by 1
- K170871: DigniCap Scalp Cooling System (2017), cited by 1

Source page: https://510kreport.com/product-code/PMC
Data by year (CSV): https://510kreport.com/product-code/PMC.csv