510(k) · Cleared
ClearedStorz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Storz Medical AG · PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Cleared on Feb 21, 2021 as substantially equivalent to DEN160037 (Sanuwave, Inc., 2017) and 1 other predicate after a 206-day review. Its family tree reaches back 2 generations to 2017. 1 later device descends from it.
- Decided
- Feb 21, 2021
- Review
- 206 days
- Class
- Class II
- Product code
- PZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN160037 (2017). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backDEN160037 dermaPACE SystemSanuwave, Inc. · 2017
- 1 generation backK191961 OrthoGoldTissue Regeneration Technologies · 2019
- This deviceK202112 Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia…Storz Medical AG · 2021
- Descendant · cites it directly · 0 of its ownK243279 DOLORCLAST Focused Shock WavesE.M.S Electro Medical Systems S.A · 2025
Most influential descendants
Showing 1 of 1 · See all- K243279DOLORCLAST Focused Shock WavesE.M.S Electro Medical Systems S.A · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN160037 | dermaPACE System | Sanuwave, Inc. | 2017 | — |
| −1 | K191961 | OrthoGold | Tissue Regeneration Technologies | 2019 | — |
| 0 (this device) | K202112 | Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece | Storz Medical AG | 2021 | — |
| +1 | 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 |
|---|---|---|
| 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 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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | DEN160037 | dermaPACE SystemSummary page 4…78.4685 Product Code: PZL Device Class: II 3. PREDICATE DEVICES Equivalence is claimed to the predicate devices: DERMAPACE device (DEN160037; primary) and the ORTHOGOLD device (K191961). 4. DEVICE DESCRIPTION The DUOLITH SD1 with the C-ACTOR Sepia Handpiece… | 2017 |
| * | K191961 | OrthoGoldSummary page 4…e Class: II 3. PREDICATE DEVICES Equivalence is claimed to the predicate devices: DERMAPACE device (DEN160037; primary) and the ORTHOGOLD device (K191961). 4. DEVICE DESCRIPTION The DUOLITH SD1 with the C-ACTOR Sepia Handpiece uses an electromagnetically generated shock… | 2019 |
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 |
|---|---|---|---|
| K243279 | DOLORCLAST Focused Shock Waves | 2025 | 0 |
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 4 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K243279 (E.M.S Electro Medical Systems S.A, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate DEN160037.
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. 2021, 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 DUOLITH SD1 T-Top & Tower System with C-ACTOR Sepia Handpiece 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 DUOLITH SD1
with C-ACTOR 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/K202112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202112: Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202112
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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