De Novo · Granted
GranteddermaPACE System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sanuwave, Inc. · PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Granted on Dec 28, 2017 as a new device type through De Novo after a 521-day review. 6 later devices descend from it.
- Decided
- Dec 28, 2017
- Review
- 521 days
- Class
- Class II
- Product code
- PZL
- Recalls
- None
6 later devices descend from it, 2 citing it directly.
- This deviceDEN160037 dermaPACE SystemSanuwave, Inc. · 2017
- Descendant · cites it directly · 5 of its ownK191961 OrthoGoldTissue Regeneration Technologies · 2019
- Descendant · 2 generations on · 2 of its ownK200926 OrthoGold 100Tissue Regeneration Technologies, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK231710 OW100SSoftwave/Trt, LLC · 2023
- Descendant · cites it directly · 1 of its ownK202112 Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia…Storz Medical AG · 2021
- Descendant · 2 generations on · 0 of its ownK243279 DOLORCLAST Focused Shock WavesE.M.S Electro Medical Systems S.A · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K191961OrthoGoldTissue Regeneration Technologies · 2019 · cites it directly5descendants
- K200926OrthoGold 100Tissue Regeneration Technologies, LLC · 2020 · 2 generations on2descendants
- K231710OW100SSoftwave/Trt, LLC · 2023 · 2 generations on1descendant
- K202112Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia HandpieceStorz Medical AG · 2021 · cites it directly1descendant
- K243279DOLORCLAST Focused Shock WavesE.M.S Electro Medical Systems S.A · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN160037 | dermaPACE System | Sanuwave, Inc. | 2017 | — |
| +1 | K191961 | OrthoGold | Tissue Regeneration Technologies | 2019 | — |
| +2 | K200926 | OrthoGold 100 | Tissue Regeneration Technologies, LLC | 2020 | — |
| +2 | K231710 | OW100S | Softwave/Trt, LLC | 2023 | — |
| +1 | K202112 | Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece | Storz Medical AG | 2021 | — |
| +2 | K243279 | DOLORCLAST Focused Shock Waves | E.M.S Electro Medical Systems S.A | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 PZL? 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 PZL device
- #1 K243279 DOLORCLAST Focused Shock Wavesscore 10.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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, K191961 (Tissue Regeneration Technologies, 2019) has gone furthest, with 5 descendants of its own.
How does its category compare?
All PZL devicesPZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PZL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PZL
Too few PZL 510(k)s in any year since 2007 to give a median.
Recalls per year · PZL
No recall names PZL since 2007.
Adverse event reports per year · PZL
No MAUDE report names PZL since 2007.
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 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SANUWAVE dermaPACE System is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The dermaPACE System is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN160037 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN160037: dermaPACE System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN160037
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