PMC
7 FDA 510(k) clearances · Product code
126 daysmedian time to decision
277 days90th percentile
7clearances measured
FDA profile
- Official device name
- Scalp Cooling System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4360
- Medical specialty
- General, Plastic Surgery
- FDA definition
- A scalp cooling system is intended to reduce or prevent the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used.
- Adverse events (MAUDE)
- 2023: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Eva Scalp Cooling System (K252289) | Stemtech Medical Devices Private Limited | 2025-11-25 |
| Portable Scalp Cooling System (K211526) | Cooler Heads Care, Inc. | 2021-10-21 |
| DigniCap Delta (K191166) | Dignitana, Inc. | 2019-06-26 |
| Paxman Scalp Cooler (K173032) | Paxman Coolers Limited | 2018-06-07 |
| DigniCap Scalp Cooling System (K170871) | Dignitana AB | 2017-07-03 |
| Paxman Scalp Cooler (K163484) | Paxman Coolers Limited | 2017-04-17 |
| Dignitana AB DigniCap System (DEN150010) | Dignitana AB | 2015-12-08 |
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Every clearance here is in the API, with alerts when new ones post.