510(k) · Cleared
Recalled · Class II · 2012Dyonics Electroblade Resector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 1, 2002 as substantially equivalent to K994365 (Smith & Nephew, Inc., 2000) after a 193-day review. Its family tree reaches back 1 generation to 2000. 52 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 1, 2002
- Review
- 193 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K994365 (2000). 52 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK994365 Dyonics ElectrobladeSmith & Nephew, Inc. · 2000
- This deviceK012314 Dyonics Electroblade ResectorSmith & Nephew, Inc. · 2002
- Descendant · cites it directly · 50 of its ownK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
- Descendant · 2 generations on · 44 of its ownK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- Descendant · 3 generations on · 42 of its ownK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- Descendant · 4 generations on · 41 of its ownK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
- Descendant · 4 generations on · 36 of its ownK102003 Xpress Balloon DeviceEntellus Medical, Inc. · 2010
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004 · cites it directly50descendants
- K072302Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · 2 generations on44descendants
- K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · 3 generations on42descendants
- K093007Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010 · 4 generations on41descendants
- K102003Xpress Balloon DeviceEntellus Medical, Inc. · 2010 · 4 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K994365 | Dyonics Electroblade | Smith & Nephew, Inc. | 2000 | — |
| 0 (this device) | K012314 | Dyonics Electroblade Resector | Smith & Nephew, Inc. | 2002 | — |
| +1 | K034004 | Diego RF Powered Dissector and Drill System Console | Gyrus Ent LLC | 2004 | — |
| +2 | K072302 | Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| +3 | K081542 | Modification to Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| +4 | K093007 | Entellus Medical Balloon Device | Entellus Medical, Inc. | 2010 | — |
| +4 | K102003 | Xpress Balloon Device | Entellus Medical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 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? (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 |
|---|---|---|---|
| * | K994365 | Dyonics ElectrobladeSummary page 1…letroBlade Resector Common Name: Arthroscopic Surgery Blade / Electrosurgical Probe Classification Name: Electrosurgical Probe Predicate Devices DYONICS ElectroBlade (K994365) Description of Device The DYONICS ElectroBlade Resector combines the rotary cutting technology of Dyonics Arthroscopic Surgery… | 2000 |
What descends from it? (52)
See all 522 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 14, 2012 | Class II | Z-2145-2012 | Error in labeling | Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated. |
| Jul 14, 2012 | Class II | Z-2144-2012 | Error in labeling | Devices labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated. |
| Nov 7, 2011 | Not classified | Z-0463-2012 | Process control | Manufacturing issue: The distal tip of the outer sheath (return electrode) may detach and become loose in the joint during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 DYONICS Electroblade Resector is indicated in arthroscopic surgical procedures of
large and small articular cavities for resection and excision of soft and osseous tissues. The
DYONICS EletroBlade Resector is effective in tissue resection and hemostasis of bleeding
vessels. It is intended for arthroscopic procedures using saline solution, Ringer’s lactate or
other conductive solutions as an irrigant under direct or video-assisted fiber-optic
visualization.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012314: Dyonics Electroblade Resector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012314
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026