510(k) · Cleared
ClearedUltrablator Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 3, 2003 as substantially equivalent to K993885 (Linvatec Corp., 2000) after an 88-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it.
- Decided
- Jun 3, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944992 (1995). 3 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK944992 ElectrodesLinvatec Corp. · 1995
- 1 generation backK993885 Ultrablator ElectrodeLinvatec Corp. · 2000
- This deviceK030720 Ultrablator ElectrodeLinvatec Corp. · 2003
- Descendant · cites it directly · 2 of its ownK050923 Lightwave Integrated Electrode Ablator and Light Wave Integrated…Conmed Linvatec · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK083281 EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction…Linvatec Corp. · 2009
- Descendant · cites it directly · 0 of its ownK052692 Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006
- Descendant · cites it directly · 0 of its ownK033748 Trident Resection AblatorLinvatec Corp. · 2003
Most influential descendants
Showing 4 of 4 · See all- K050923Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode Suction AblatorConmed Linvatec · 2005 · cites it directly2descendants
- K083281EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator, Model…Linvatec Corp. · 2009 · 2 generations on0descendants
- K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006 · cites it directly0descendants
- K033748Trident Resection AblatorLinvatec Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944992 | Electrodes | Linvatec Corp. | 1995 | — |
| −1 | K993885 | Ultrablator Electrode | Linvatec Corp. | 2000 | — |
| 0 (this device) | K030720 | Ultrablator Electrode | Linvatec Corp. | 2003 | — |
| +1 | K050923 | Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode… | Conmed Linvatec | 2005 | 1 |
| +2 | K083281 | EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator… | Linvatec Corp. | 2009 | — |
| +1 | K052692 | Suretek Medical Reprocessed Electrosurgical Electrodes | Suretek Medical | 2006 | — |
| +1 | K033748 | Trident Resection Ablator | Linvatec Corp. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 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? (1)
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 |
|---|---|---|---|
| * | K993885 | Ultrablator ElectrodeSummary page 2…ry of Safety and Effectiveness UltrAblator Electrode 510(k)# k 0 36, March 6,2003 Page 2 of 2 D. Predicate/Legally Marketed Devices UltrAblator Electrode K993885 Linvatec Corporation E. Device Description The UltrAblator Electrode is a sterile, single-use monopolar electrode… | 2000 |
What descends from it? (4)
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?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 4.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K050923 (Conmed Linvatec, 2005) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K993885.
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?
The UltrAblator Electrode is intended to be used in arthroscopic applications of resection, ablation, tissue modification, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues. Areas of application include knee, shoulder, ankle, wrist and elbow arthroscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030720 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030720: Ultrablator Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030720
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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