510(k) · Cleared
ClearedE Blator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Deantronics Taiwan, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 1, 2025 as substantially equivalent to K231126 (E Surgical, LLC, 2023) after a 103-day review. Its family tree reaches back 17 generations to 2001.
- Decided
- Oct 1, 2025
- Review
- 103 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K011083 (2001). 82 ancestors in all, the oldest K852143 (1985). No later device cites it as a predicate yet.
- Root · 17 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 13 generations between
- 3 generations backK152777 Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · Recalled
- 2 generations backK161558 Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and…Bovie Medical Corporation · 2016 · Recalled
- 1 generation backK231126 Eblator DeviceE Surgical, LLC · 2023
- This deviceK251899 E BlatorNew Deantronics Taiwan, Ltd. · 2025
Show all 17 generations
- Root · 17 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 16 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 15 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 14 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 13 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 12 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 11 generations backK052686 Arthrocare ArthrowandsArthrocare Corp. · 2005
- 10 generations backK070958 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2007
- 9 generations backK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 8 generations backK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 7 generations backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- 6 generations backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 5 generations backK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 4 generations backK120791 Ambient Turboflash 90 IfsArthocare Corporation · 2012
- 3 generations backK152777 Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · Recalled
- 2 generations backK161558 Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and…Bovie Medical Corporation · 2016 · Recalled
- 1 generation backK231126 Eblator DeviceE Surgical, LLC · 2023
- This deviceK251899 E BlatorNew Deantronics Taiwan, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −16 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −15 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −14 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −13 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −12 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −11 | K052686 | Arthrocare Arthrowands | Arthrocare Corp. | 2005 | — |
| −10 | K070958 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −9 | K071963 | Modification to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −8 | K072865 | Modificaton to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −7 | K082323 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | — |
| −6 | K082980 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 12 |
| −5 | K083306 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 1 |
| −4 | K120791 | Ambient Turboflash 90 Ifs | Arthocare Corporation | 2012 | — |
| −3 | K152777 | Bovie Disposable Bipolar Ablator | Bovie Medical Corporation | 2016 | 2 |
| −2 | K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating… | Bovie Medical Corporation | 2016 | 3 |
| −1 | K231126 | Eblator Device | E Surgical, LLC | 2023 | — |
| 0 (this device) | K251899 | E Blator | New Deantronics Taiwan, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 9 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 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 |
|---|---|---|---|
| * | K231126 | Eblator DeviceSummary page 5…ice Eblator Device Manufacturer E Surgical, LLC Common Name Electrosurgical Ablator Premarket Notification # K231126 Classification 21 CFR 878.4400 Classification & Product Code Class 2, GEI Reference Device 1: Reference Devi… | 2023 |
| † | K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm… | 2016 |
| † | K161581 | Arthrex Synergy RF System | 2016 |
| † | K023986 | Arthrex Opes Electrodes and Accessories | 2002 |
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 24 years and passes through 5 companies; a new generation was cleared every 6 months on median.
- 15 of the 82 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. 2025, 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 E Blator is intended for general arthroscopic applications, which include cutting, vaporization, and coagulation. This device is intended to be used in conjunction with a general purpose electrosurgical generator via a standard active lead and a standard return lead connection. The device is only operable when activated in an appropriate conductive media, such as a standard saline solution.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251899 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251899: E Blator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251899
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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