FDA product code · General and plastic surgery
Scalp Cooling System
7 FDA decisions since 2015. 510(k) reviews decided 2021–2025 took a median of 141 days (half between 133 and 149). 1 recall names this code; it is not Class I. The most-cited predicate is DEN150010, named by 2 later devices.
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.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PMC at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · PMC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PMC
Too few PMC 510(k)s in any year since 2007 to give a median.
Recalls per year · PMC
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PMC
8in 2025
MAUDE reports naming product code PMC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 1 | — | 1 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
Planning a device in PMC? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report