510(k) · Cleared
ClearedThermomed 1.8
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermosurgery Technologies, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 1, 2007 as substantially equivalent to K021117 (Thermosurgery Technologies, Inc., 2002) and 3 other predicates after a 44-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Feb 1, 2007
- Review
- 44 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K894166 (1989). 4 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894166 | Thermosurgery TM | Rdm Intl., Inc. | 1989 | — |
| −1 | K021117 | Tti Thermomed Model 1.8 Instrument | Thermosurgery Technologies, Inc. | 2002 | — |
| 0 (this device) | K063748 | Thermomed 1.8 | Thermosurgery Technologies, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1997 | 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? (4)
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 |
|---|---|---|---|
| * | K021117 | Tti Thermomed Model 1.8 InstrumentSummary page 1…Coagulation Accessories, Class II Product Code GEl / 878.4000/Class II Substantial ThermoMed Model 1.8 (K021117) Equivalence Thermosurgery (K8941 66) ConMed Hyfrecator 2000 (K970493) Birt… | 2002 |
| * | K894166 | Thermosurgery TMSummary page 1…ies, Class II Product Code GEl / 878.4000/Class II Substantial ThermoMed Model 1.8 (K021117) Equivalence Thermosurgery (K8941 66) ConMed Hyfrecator 2000 (K970493) Birtcher (K800617) Device Class 1I C… | 1989 |
| * | K970493 | Hyfrecator 2000Summary page 1…GEl / 878.4000/Class II Substantial ThermoMed Model 1.8 (K021117) Equivalence Thermosurgery (K8941 66) ConMed Hyfrecator 2000 (K970493) Birtcher (K800617) Device Class 1I Classification Device Description The ThermoMed Model… | 1997 |
| * | K800617 | Hyfrecator, #733Summary page 1…ThermoMed Model 1.8 (K021117) Equivalence Thermosurgery (K8941 66) ConMed Hyfrecator 2000 (K970493) Birtcher (K800617) Device Class 1I Classification Device Description The ThermoMed Model 1.8 is a battery-operated device… | 1980 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 2 companies; a new generation was cleared every 12.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
The device is intended to treat benign superficial dermatological indications that includes; warts, molluscum contagiosm, angioma, fibroma, seborrheic keratoses, acrochordon, syringoma, hydrocystoma, calvus, actinic keratoses, keloids, epidermoid cysts, cystic acne, cutaneous leishmaniasis, atypical mycobacteria, and dermatophytosis. In addition, it is intended to treat basal cell carcinoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063748 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063748: Thermomed 1.8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063748
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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