510(k) · Cleared
ClearedDR. Oppel ST-501
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sometech Incorporated · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 8, 2005 as substantially equivalent to K000961 (Aaron Medical Industries, 2000) and 2 other predicates after a 51-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Sep 8, 2005
- Review
- 51 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K933157 (1994). 7 ancestors in all, the oldest K931338 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK933157 Erbotom Icc 200Erbe USA, Inc. · 1994
- 1 generation backK013255 Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001
- This deviceK051956 DR. Oppel ST-501Sometech Incorporated · 2005
- Descendant · cites it directly · 0 of its ownK134036 Wavetronic 5000 Digital HF Surgical UnitLoktal Medical Electronics Ind. Com. Ltda- Epp · 2015
Most influential descendants
Showing 1 of 1 · See all- K134036Wavetronic 5000 Digital HF Surgical UnitLoktal Medical Electronics Ind. Com. Ltda- Epp · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933157 | Erbotom Icc 200 | Erbe USA, Inc. | 1994 | — |
| −1 | K013255 | Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF | Ellman Intl., Inc. | 2001 | — |
| 0 (this device) | K051956 | DR. Oppel ST-501 | Sometech Incorporated | 2005 | — |
| +1 | K134036 | Wavetronic 5000 Digital HF Surgical Unit | Loktal Medical Electronics Ind. Com. Ltda- Epp | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K000961 | Aaron 900 High Frequency Dessiccator/HandpieceSummary page 1…ame - Electrosurgical cutting and coagulation device and Accessories 3. Predicate Device: Aaron 900 High Frequency Desiccator/Handpiece, Aaron Medical Industries, K000961 Aaron Reusable Electrosurgical Electrode, Aaron Medical Industries, KO 14201 Surgitron 120 IEC, Ellman International,… | 2000 |
| * | K014201 | Aaron Reusable Electrosurgical Electrode | 2002 |
| * | K013255 | Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFSummary page 1…Aaron Medical Industries, K000961 Aaron Reusable Electrosurgical Electrode, Aaron Medical Industries, KO 14201 Surgitron 120 IEC, Ellman International, Inc., K013255 4. Classifications & Citations: 21CFR 878.4400, GEl Class 2 510(k) Guidance Document for General Surgical Elec… | 2001 |
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 |
|---|---|---|---|
| K134036 | Wavetronic 5000 Digital HF Surgical Unit | 2015 | 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 11 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K134036 (Loktal Medical Electronics Ind. Com. Ltda- Epp, 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K000961.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
Dr. OPPEL ST-501 is intended for the removal and destruction of skin legions and the coagulation of tissue. Non-sterile and reusable electrodes are used in conjunction with an electrosurgical handpiece and generator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051956 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051956: DR. Oppel ST-501.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051956
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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