510(k) · Cleared
ClearedPeak Plasmablade 3.OS Tissue Dissection Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peak Surgical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 13, 2010 as substantially equivalent to K082786 (Peak Surgical, Inc., 2008) after a 134-day review. Its family tree reaches back 4 generations to 1994. 8 later devices descend from it.
- Decided
- Apr 13, 2010
- Review
- 134 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K933157 (1994). 20 ancestors in all, the oldest K780977 (1978). 8 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK933157 Erbotom Icc 200Erbe USA, Inc. · 1994
- 3 generations backK013255 Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001
- 2 generations backK061174 Surgi-MaxEllman Int'L, Inc. · 2006
- 1 generation backK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
- This deviceK093695 Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK181257 PlasmaBlade X 3.0S, PlasmaBlade X 4.0Medtronic Advanced Energy · 2018
- Descendant · cites it directly · 2 of its ownK193579 PlasmaBlade X 3.0S LIGHTMedtronic Navigation · 2020
- Descendant · 2 generations on · 1 of its ownK242266 PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments · 2024
- Descendant · cites it directly · 1 of its ownK162053 PhotonBladeInvuity, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 0 of its ownK250483 PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K181257PlasmaBlade X 3.0S, PlasmaBlade X 4.0Medtronic Advanced Energy · 2018 · cites it directly3descendants
- K193579PlasmaBlade X 3.0S LIGHTMedtronic Navigation · 2020 · cites it directly2descendants
- K242266PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments · 2024 · 2 generations on1descendant
- K162053PhotonBladeInvuity, Inc. · 2016 · cites it directly1descendant
- K250483PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933157 | Erbotom Icc 200 | Erbe USA, Inc. | 1994 | — |
| −3 | K013255 | Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF | Ellman Intl., Inc. | 2001 | — |
| −2 | K061174 | Surgi-Max | Ellman Int'L, Inc. | 2006 | — |
| −1 | K082786 | Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection… | Peak Surgical, Inc. | 2008 | 1 |
| 0 (this device) | 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 | — |
| +1 | K193579 | PlasmaBlade X 3.0S LIGHT | Medtronic Navigation | 2020 | — |
| +2 | K242266 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | Stryker Instruments | 2024 | — |
| +1 | K162053 | PhotonBlade | Invuity, Inc. | 2016 | 1 |
| +3 | 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K082786 | Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesSummary page 1…g and Coagulation Device and Accessories Regulation Number: 21 CFR § 878.4400 Product Code: GEI Regulatory Class: Class Il Predicate Devices: PEAK PlasmaBlade® 4.0 (K082786) Device Description: The PEAK PlasmaBlade® 3.0S consists of a single insulated bendable blade, telescoping shaft that can be co… | 2008 |
What descends from it? (8)
5 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 16 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 5 of the 20 ancestors have a recall of any class.
- Of its descendants, K181257 (Medtronic Advanced Energy, 2018) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K082786.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 PEAK PlasmaBlade® 3.0S Tissue Dissection Device 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 surgical procedures.
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/K093695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093695: Peak Plasmablade 3.OS Tissue Dissection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093695
Report an extraction error
Are you the manufacturer?
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