510(k) · Cleared
ClearedPlasmaBlade X 3.0S LIGHT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 24, 2020 as substantially equivalent to K181257 (Medtronic Advanced Energy, 2018) and 1 other predicate after a 92-day review. Its family tree reaches back 6 generations to 1994. 2 later devices descend from it.
- Decided
- Mar 24, 2020
- Review
- 92 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K933157 (1994). 22 ancestors in all, the oldest K780977 (1978). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK933157 Erbotom Icc 200Erbe USA, Inc. · 1994
- 5 generations backK013255 Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001
- 4 generations backK061174 Surgi-MaxEllman Int'L, Inc. · 2006
- 3 generations backK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
- 2 generations backK093695 Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010
- 1 generation backK181257 PlasmaBlade X 3.0S, PlasmaBlade X 4.0Medtronic Advanced Energy · 2018
- This deviceK193579 PlasmaBlade X 3.0S LIGHTMedtronic Navigation · 2020
- Descendant · cites it directly · 1 of its ownK242266 PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments · 2024
- Descendant · 2 generations on · 0 of its ownK250483 PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933157 | Erbotom Icc 200 | Erbe USA, Inc. | 1994 | — |
| −5 | K013255 | Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF | Ellman Intl., Inc. | 2001 | — |
| −4 | K061174 | Surgi-Max | Ellman Int'L, Inc. | 2006 | — |
| −3 | K082786 | Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection… | Peak Surgical, Inc. | 2008 | 1 |
| −2 | K093695 | Peak Plasmablade 3.OS Tissue Dissection Device | Peak Surgical, Inc. | 2010 | — |
| −1 | K181257 | PlasmaBlade X 3.0S, PlasmaBlade X 4.0 | Medtronic Advanced Energy | 2018 | — |
| 0 (this device) | K193579 | PlasmaBlade X 3.0S LIGHT | Medtronic Navigation | 2020 | — |
| +1 | K242266 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | Stryker Instruments | 2024 | — |
| +2 | K250483 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | Stryker Instruments | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K181257 | PlasmaBlade X 3.0S, PlasmaBlade X 4.0Summary page 4…accessories (21 CFR 878.4400) Product Code: GEI Predicate Devices: PlasmaBlade X 3.0S (K181257) PlasmaBlade 3.0S (K093695) Reference Device: PhotonBlade (K1620… | 2018 |
| * | K093695 | Peak Plasmablade 3.OS Tissue Dissection DeviceSummary page 4…Product Code: GEI Predicate Devices: PlasmaBlade X 3.0S (K181257) PlasmaBlade 3.0S (K093695) Reference Device: PhotonBlade (K162053) Device Description: The PlasmaBlade™ X 3.0… | 2010 |
| † | K162053 | PhotonBlade | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242266 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | 2024 | 1 |
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 26 years and passes through 6 companies; a new generation was cleared every 4.6 years on median.
- 5 of the 22 ancestors have a recall of any class.
- Of its descendants, K242266 (Stryker Instruments, 2024) has gone furthest, with 1 descendant 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. 2020, 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 Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193579 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193579: PlasmaBlade X 3.0S LIGHT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193579
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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