De Novo · Granted
GrantedDignitana AB DigniCap System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dignitana AB · PMC Scalp Cooling System
Granted on Dec 8, 2015 as a new device type through De Novo after a 277-day review. 6 later devices descend from it.
- Decided
- Dec 8, 2015
- Review
- 277 days
- Class
- Class II
- Product code
- PMC
- Recalls
- None
6 later devices descend from it, 2 citing it directly.
- This deviceDEN150010 Dignitana AB DigniCap SystemDignitana AB · 2015
- Descendant · cites it directly · 2 of its ownK170871 DigniCap Scalp Cooling SystemDignitana AB · 2017
- Descendant · cites it directly · 2 of its ownK163484 Paxman Scalp CoolerPaxman Coolers Limited · 2017
- Descendant · 2 generations on · 1 of its ownK191166 DigniCap DeltaDignitana, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK173032 Paxman Scalp CoolerPaxman Coolers Limited · 2018
- Descendant · 3 generations on · 0 of its ownK252289 Eva Scalp Cooling SystemStemtech Medical Devices Private Limited · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K170871DigniCap Scalp Cooling SystemDignitana AB · 2017 · cites it directly2descendants
- K163484Paxman Scalp CoolerPaxman Coolers Limited · 2017 · cites it directly2descendants
- K191166DigniCap DeltaDignitana, Inc. · 2019 · 2 generations on1descendant
- K173032Paxman Scalp CoolerPaxman Coolers Limited · 2018 · 2 generations on1descendant
- K252289Eva Scalp Cooling SystemStemtech Medical Devices Private Limited · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN150010 | Dignitana AB DigniCap System | Dignitana AB | 2015 | — |
| +1 | K170871 | DigniCap Scalp Cooling System | Dignitana AB | 2017 | — |
| +1 | K163484 | Paxman Scalp Cooler | Paxman Coolers Limited | 2017 | — |
| +2 | K191166 | DigniCap Delta | Dignitana, Inc. | 2019 | 1 |
| +2 | K173032 | Paxman Scalp Cooler | Paxman Coolers Limited | 2018 | — |
| +3 | K252289 | Eva Scalp Cooling System | Stemtech Medical Devices Private Limited | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo 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 K252289 Eva Scalp Cooling Systemscore 11.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K170871 (Dignitana AB, 2017) has gone furthest, with 2 descendants of its own.
How does its category compare?
All PMC devicesPMC Scalp Cooling System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
indicated to reduce the likelihood of chemotherapy-induced alopecia in women with breast cancer
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN150010 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN150010: Dignitana AB DigniCap System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN150010
Report an extraction error
Are you the manufacturer?
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