510(k) · Cleared
ClearedPlasmaBlade T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Advanced Energy · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 13, 2017 as substantially equivalent to K143175 (Medtronic Advanced Energy, 2014) and 3 other predicates after a 43-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Apr 13, 2017
- Review
- 43 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K954171 (1996). 33 ancestors in all, the oldest K780977 (1978). No later device cites it as a predicate yet.
- Root · 8 generations backK954171 Arco-MBC, Arco MCHoll Meditronics, Inc. · 1996
- 7 generations backK993265 Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600Soring GmbH Medizintechnik · 1999
- 6 generations backK024059 MBC SeriesSoring GmbH Medizintechnik · 2003
- 5 generations backK052859 Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 2005 · Recalled
- 4 generations backK063639 Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Tissuelink Medical, Inc. · 2007
- 3 generations backK111732 Aquamantys SBS 5.0 Sheated Biopolar SealerSalient Surgical Technologies, Inc. · 2011
- 2 generations backK132974 Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini…Medtronic Advanced Energy, LLC · 2013
- 1 generation backK143175 AEx Generator; PlasmaBlade TMedtronic Advanced Energy · 2014
- This deviceK170610 PlasmaBlade TMedtronic Advanced Energy · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954171 | Arco-MBC, Arco MC | Holl Meditronics, Inc. | 1996 | — |
| −7 | K993265 | Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600 | Soring GmbH Medizintechnik | 1999 | — |
| −6 | K024059 | MBC Series | Soring GmbH Medizintechnik | 2003 | — |
| −5 | K052859 | Aquamantys Pump Generator System | Tissuelink Medical, Inc. | 2005 | 1 |
| −4 | K063639 | Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1 | Tissuelink Medical, Inc. | 2007 | — |
| −3 | K111732 | Aquamantys SBS 5.0 Sheated Biopolar Sealer | Salient Surgical Technologies, Inc. | 2011 | — |
| −2 | K132974 | Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4… | Medtronic Advanced Energy, LLC | 2013 | — |
| −1 | K143175 | AEx Generator; PlasmaBlade T | Medtronic Advanced Energy | 2014 | — |
| 0 (this device) | K170610 | PlasmaBlade T | Medtronic Advanced Energy | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 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? (4)
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 |
|---|---|---|---|
| * | K143175 | AEx Generator; PlasmaBlade TSummary page 4…nd coagulation device and accessories (21 CFR 878.4400) Product Code: GEI Predicate Device: PlasmaBlade T and AEX Generator (K143175) Aquamantys SBS 5.0 (K111732, K132974) PlasmaBlade 3.0S (K093695) Device Desc… | 2014 |
| * | K111732 | Aquamantys SBS 5.0 Sheated Biopolar SealerSummary page 4…(21 CFR 878.4400) Product Code: GEI Predicate Device: PlasmaBlade T and AEX Generator (K143175) Aquamantys SBS 5.0 (K111732, K132974) PlasmaBlade 3.0S (K093695) Device Description: The proposed single‐use disposable acces… | 2011 |
| * | K132974 | Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein…Summary page 4…(21 CFR 878.4400) Product Code: GEI Predicate Device: PlasmaBlade T and AEX Generator (K143175) Aquamantys SBS 5.0 (K111732, K132974) PlasmaBlade 3.0S (K093695) Device Description: The proposed single‐use disposable accessory devi… | 2013 |
| * | K093695 | Peak Plasmablade 3.OS Tissue Dissection DeviceSummary page 4…dicate Device: PlasmaBlade T and AEX Generator (K143175) Aquamantys SBS 5.0 (K111732, K132974) PlasmaBlade 3.0S (K093695) Device Description: The proposed single‐use disposable accessory device, the PlasmaBlade T monop… | 2010 |
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 21 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 8 of the 33 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. 2017, 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 PlasmaBlade T is a monopolar, single use, sterile, disposable device intended for use with the AEX Generator. The device delivers RF energy concurrent with saline for hemostatic sealing and coagulation of soft tissue and bone and RF energy for cutting and coagulation of soft tissue. It is intended for, but not limited to, General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic…
Read the full statement (109 words)
The PlasmaBlade T is a monopolar, single use, sterile, disposable device intended for use with the AEX Generator. The device delivers RF energy concurrent with saline for hemostatic sealing and coagulation of soft tissue and bone and RF energy for cutting and coagulation of soft tissue. It is intended for, but not limited to, General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal, Thoracic, and Open abdominal surgery procedures.
The PlasmaBlade T should not be used on small appendages or body parts, as in circumcision. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170610 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170610: PlasmaBlade T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170610
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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