510(k) · Cleared
ClearedOratec Interventions Model Ora 50 Electrothermal Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oratec Interventions, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 12, 1996 after a 62-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Dec 12, 1996
- Review
- 62 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK964071 Oratec Interventions Model Ora 50 Electrothermal GeneratorOratec Interventions, Inc. · 1996
- Descendant · cites it directly · 3 of its ownK011190 Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc. · 2002
- Descendant · 2 generations on · 2 of its ownK020126 Modification to Surx Radiofrequency Electrosurgical Generator System…Surx, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK020952 Surx RF SystemSurx, Inc. · 2002
- Descendant · 3 generations on · 0 of its ownK042132 Novasys Transurethral RF SystemNovasys Medical, Inc. · 2004 · Recalled
- Descendant · cites it directly · 0 of its ownK994333 Ora-50 Electrothermal System and AccessoriesOratec Interventions, Inc. · 2000
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K011190Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System)Surx, Inc. · 2002 · cites it directly3descendants
- K020126Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc. · 2002 · 2 generations on2descendants
- K020952Surx RF SystemSurx, Inc. · 2002 · 2 generations on1descendant
- K042132Novasys Transurethral RF SystemNovasys Medical, Inc. · 2004 · 3 generations on0descendants
- K994333Ora-50 Electrothermal System and AccessoriesOratec Interventions, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964071 | Oratec Interventions Model Ora 50 Electrothermal Generator | Oratec Interventions, Inc. | 1996 | — |
| +1 | K011190 | Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP… | Surx, Inc. | 2002 | — |
| +2 | K020126 | Modification to Surx Radiofrequency Electrosurgical Generator System and… | Surx, Inc. | 2002 | — |
| +2 | K020952 | Surx RF System | Surx, Inc. | 2002 | — |
| +3 | K042132 | Novasys Transurethral RF System | Novasys Medical, Inc. | 2004 | 1 |
| +1 | K994333 | Ora-50 Electrothermal System and Accessories | Oratec Interventions, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
3 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, K011190 (Surx, Inc., 2002) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K964071 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964071: Oratec Interventions Model Ora 50 Electrothermal Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964071
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026