510(k) · Cleared
ClearedEva Scalp Cooling System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stemtech Medical Devices Private Limited · PMC Scalp Cooling System
Cleared on Nov 25, 2025 as substantially equivalent to K191166 (Dignitana, Inc., 2019) after a 125-day review. Its family tree reaches back 3 generations to 2015.
- Decided
- Nov 25, 2025
- Review
- 125 days
- Class
- Class II
- Product code
- PMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN150010 (2015). No later device cites it as a predicate yet.
- Root · 3 generations backDEN150010 Dignitana AB DigniCap SystemDignitana AB · 2015
- 2 generations backK170871 DigniCap Scalp Cooling SystemDignitana AB · 2017
- 1 generation backK191166 DigniCap DeltaDignitana, Inc. · 2019 · Recalled
- This deviceK252289 Eva Scalp Cooling SystemStemtech Medical Devices Private Limited · 2025
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PMC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PMC device
- #1 K211526 Portable Scalp Cooling Systemscore 2.8 · 3 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K191166 | DigniCap DeltaSummary page 6…Page 2 of 5 Device name: DigniCap Delta Scalp Cooling System 510(k) number: K191166 Manufacturer: Dignitana, Inc. The DigniCap Delta Scalp Cooling System (“DigniCap Delta”) is a device that i… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All PMC devicesPMC Scalp Cooling System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Eva Scalp Cooling System is indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252289: Eva Scalp Cooling System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252289
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026