510(k) · Cleared
Recalled · Class II · 2021DigniCap Delta
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dignitana, Inc. · PMC Scalp Cooling System
Cleared on Jun 26, 2019 as substantially equivalent to K170871 (Dignitana AB, 2017) after a 56-day review. Its family tree reaches back 2 generations to 2015. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 26, 2019
- Review
- 56 days
- Class
- Class II
- Product code
- PMC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN150010 (2015). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backDEN150010 Dignitana AB DigniCap SystemDignitana AB · 2015
- 1 generation backK170871 DigniCap Scalp Cooling SystemDignitana AB · 2017
- This deviceK191166 DigniCap DeltaDignitana, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK252289 Eva Scalp Cooling SystemStemtech Medical Devices Private Limited · 2025
Most influential descendants
Showing 1 of 1 · See all- K252289Eva Scalp Cooling SystemStemtech Medical Devices Private Limited · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN150010 | Dignitana AB DigniCap System | Dignitana AB | 2015 | — |
| −1 | K170871 | DigniCap Scalp Cooling System | Dignitana AB | 2017 | — |
| 0 (this device) | K191166 | DigniCap Delta | Dignitana, Inc. | 2019 | — |
| +1 | K252289 | Eva Scalp Cooling System | Stemtech Medical Devices Private Limited | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K170871 | DigniCap Scalp Cooling SystemSummary page 5…5 === 510(k) SUMMARY PREDICATE DEVICE(S) DigniCap Delta is substantially equivalent to the predicate device, the Dignitana DigniCap Scalp Cooling System, cleared under K170871. DigniCap Delta is intended for use in the same population, with the same mechanism of action and Indications for Use. Any differ… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252289 | Eva Scalp Cooling System | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 5, 2021 | Class II | Z-0825-2022 | Labeling design | Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patients and instructions for the application of the headband. Additionally, IFU updated to include warnings for risk of condensation build up… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K252289 (Stemtech Medical Devices Private Limited, 2025) has gone furthest, with 0 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. 2019, 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 Delta® 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/K191166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191166: DigniCap Delta.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191166
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