510(k) · Cleared
ClearedUniblate Electrosurgical Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AngioDynamics, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 3, 2008 as substantially equivalent to K070101 (Rita Medical Systems, Inc., 2007) and 2 other predicates after a 135-day review. Its family tree reaches back 6 generations to 1987. 8 later devices descend from it.
- Decided
- Jul 3, 2008
- Review
- 135 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K870028 (1987). 20 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 5 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 4 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 3 generations backK021329 Rita SystemRita Medical Systems · 2002
- 2 generations backK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- 1 generation backK052796 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- This deviceK080451 Uniblate Electrosurgical DeviceAngioDynamics, Inc. · 2008
- Descendant · cites it directly · 7 of its ownK161949 OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2017
- Descendant · cites it directly · 5 of its ownK182497 OsteoCool RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK221074 OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser…Stryker Corporation · 2022
- Descendant · 2 generations on · 1 of its ownK233830 OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK253656 OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K161949OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2017 · cites it directly7descendants
- K182497OsteoCool RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · 2019 · cites it directly5descendants
- K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation · 2022 · 2 generations on2descendants
- K233830OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · 2024 · 2 generations on1descendant
- K253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −5 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −4 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −3 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| −2 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| −1 | K052796 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| 0 (this device) | K080451 | Uniblate Electrosurgical Device | AngioDynamics, Inc. | 2008 | — |
| +1 | K161949 | OsteoCool V-3 RF Ablation System | Baylis Medical Company, Inc. | 2017 | — |
| +1 | K182497 | OsteoCool RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +2 | K221074 | OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device | Stryker Corporation | 2022 | — |
| +2 | K233830 | OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2024 | — |
| +3 | K253656 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 3 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K070101 | Uniblate Electrosurgical DeviceSummary page 1…e: GEI Regulatory Class: II Legally marketeddevice to which equivalence is claimed: Angiodynamics Uniblate Electrosurgical Device, 510(k) K070101 Angiodynamics (formerly RITA Medical Systems) Starburst Electrosurgical Device 510(k) K030967 Valleylab Cool-Tip Electrosurgical… | 2007 |
| * | K030967 | Rita Starburst Sde Electrosurgical DeviceSummary page 1…ivalence is claimed: Angiodynamics Uniblate Electrosurgical Device, 510(k) K070101 Angiodynamics (formerly RITA Medical Systems) Starburst Electrosurgical Device 510(k) K030967 Valleylab Cool-Tip Electrosurgical probe, 510(k) K052796 Intended Use / Indications The AngioDynamics Uniblate System is inten… | 2003 |
| * | K052796 | Cool-Tip RF Generator, Cool-Tip RF System AccessoriesSummary page 1…cal Device, 510(k) K070101 Angiodynamics (formerly RITA Medical Systems) Starburst Electrosurgical Device 510(k) K030967 Valleylab Cool-Tip Electrosurgical probe, 510(k) K052796 Intended Use / Indications The AngioDynamics Uniblate System is intended for coagulation and ablation of tissue during percuta… | 2006 |
What descends from it? (8)
2 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 21 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 20 ancestors have a recall of any class.
- Of its descendants, K161949 (Baylis Medical Company, Inc., 2017) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K070101.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 AngioDynamics Uniblate Electrosurgical Device is intended for coagulation and ablation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures such as partial or complete ablation of non-resectable liver lesions, osteoid osteoma, and palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080451: Uniblate Electrosurgical Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080451
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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