FDA product code PMC: Scalp Cooling System
PMC is the FDA product code for scalp cooling system. It is a Class II device, regulated under 21 CFR 878.4360 and reviewed by the General and Plastic Surgery panel. FDA has cleared 6 510(k) submissions under PMC, 1 in the last five years, from 5 different applicants. The average 510(k) review took 136 days (median 126); 125 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for PMC devices, 1 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Scalp Cooling System |
| Device class | Class II |
| Regulation | 21 CFR 878.4360 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for PMC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 114 |
| 2018 | 1 | 252 |
| 2019 | 1 | 56 |
| 2021 | 1 | 157 |
| 2025 | 1 | 125 |
Compare with all 510(k) review times · Search every PMC clearance
Top PMC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Paxman Coolers Limited | 2 | 2018-06-07 |
| Stemtech Medical Devices Private Limited | 1 | 2025-11-25 |
| Cooler Heads Care, Inc. | 1 | 2021-10-21 |
| Dignitana, Inc. | 1 | 2019-06-26 |
| Dignitana AB | 1 | 2017-07-03 |
Most recent PMC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252289 | Stemtech Medical Devices Private Limited | Eva Scalp Cooling System | 2025-11-25 | 125 |
| K211526 | Cooler Heads Care, Inc. | Portable Scalp Cooling System | 2021-10-21 | 157 |
| K191166 | Dignitana, Inc. | DigniCap Delta | 2019-06-26 | 56 |
| K173032 | Paxman Coolers Limited | Paxman Scalp Cooler | 2018-06-07 | 252 |
| K170871 | Dignitana AB | DigniCap Scalp Cooling System | 2017-07-03 | 102 |
Recalls for PMC devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2021-11-05.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code PMC?
PMC is the FDA product code for scalp cooling system. It is a Class II device, regulated under 21 CFR 878.4360 and reviewed by the General and Plastic Surgery panel.
What device class is PMC?
Class II, regulation 21 CFR 878.4360. Typical premarket route: 510(k).
How long does a 510(k) take for product code PMC?
Across 6 cleared submissions the average was 136 days from receipt to decision (median 126).
Which companies have the most PMC clearances?
Paxman Coolers Limited (2); Stemtech Medical Devices Private Limited (1); Cooler Heads Care, Inc. (1); Dignitana, Inc. (1); Dignitana AB (1).
Have PMC devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-11-05.
Next steps
- Run an FDA pathway report with predicate devices for product code PMC
- Run a recall and safety report across every PMC manufacturer
- Watch product code PMC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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