510(k) · Cleared
ClearedDigniCap Scalp Cooling System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dignitana AB · PMC Scalp Cooling System
Cleared on Jul 3, 2017 as substantially equivalent to DEN150010 (Dignitana AB, 2015) after a 102-day review. Its family tree reaches back 1 generation to 2015. 2 later devices descend from it.
- Decided
- Jul 3, 2017
- Review
- 102 days
- Class
- Class II
- Product code
- PMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN150010 (2015). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN150010 Dignitana AB DigniCap SystemDignitana AB · 2015
- This deviceK170871 DigniCap Scalp Cooling SystemDignitana AB · 2017
- Descendant · cites it directly · 1 of its ownK191166 DigniCap DeltaDignitana, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK252289 Eva Scalp Cooling SystemStemtech Medical Devices Private Limited · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN150010 | Dignitana AB DigniCap System | Dignitana AB | 2015 | — |
| 0 (this device) | K170871 | DigniCap Scalp Cooling System | Dignitana AB | 2017 | — |
| +1 | K191166 | DigniCap Delta | Dignitana, Inc. | 2019 | 1 |
| +2 | K252289 | Eva Scalp Cooling System | Stemtech Medical Devices Private Limited | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
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 K252289 Eva Scalp Cooling Systemscore 11.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | DEN150010 | Dignitana AB DigniCap SystemSummary page 4…ption Device Device / Classification General & Plastic Surgery Panel Predicate Device DigniCap® Scalp Cooling System DEN150010 Description of Device The DigniCap® Scalp Cooling System consists of a computer con… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191166 | DigniCap Delta | 2019 | 1 |
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?
How does its category compare?
All PMC devicesPMC Scalp Cooling System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 DigniCap® Scalp Cooling System is indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170871 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170871: DigniCap Scalp Cooling System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170871
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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