510(k) · Cleared
Recalled · Class II · 2013Aquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer with Cutting
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Salient Surgical Technologies, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 9, 2011 as substantially equivalent to K052859 (Tissuelink Medical, Inc., 2005) and 2 other predicates after a 126-day review. Its family tree reaches back 4 generations to 1996. 3 later devices descend from it. It has been recalled once.
- Decided
- Sep 9, 2011
- Review
- 126 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K954171 (1996). 9 ancestors in all, the oldest K813071 (1981). 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK954171 Arco-MBC, Arco MCHoll Meditronics, Inc. · 1996
- 3 generations backK993265 Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600Soring GmbH Medizintechnik · 1999
- 2 generations backK024059 MBC SeriesSoring GmbH Medizintechnik · 2003
- 1 generation backK052859 Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 2005 · Recalled
- This deviceK111285 Aquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer with…Salient Surgical Technologies, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK120537 AQUAMANTYS3 9.5 XL Bipolar SealerMedtronic, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK211203 Green OR Reprocessed Aquamantys Bipolar SealerGreen Or, LLC · 2022
- Descendant · cites it directly · 0 of its ownK121290 AQUAMANTRYS3 BSC 9.1SMedtronic, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954171 | Arco-MBC, Arco MC | Holl Meditronics, Inc. | 1996 | — |
| −3 | K993265 | Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600 | Soring GmbH Medizintechnik | 1999 | — |
| −2 | K024059 | MBC Series | Soring GmbH Medizintechnik | 2003 | — |
| −1 | K052859 | Aquamantys Pump Generator System | Tissuelink Medical, Inc. | 2005 | 1 |
| 0 (this device) | K111285 | Aquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer with Cutting | Salient Surgical Technologies, Inc. | 2011 | — |
| +1 | K120537 | AQUAMANTYS3 9.5 XL Bipolar Sealer | Medtronic, Inc. | 2012 | — |
| +1 | K211203 | Green OR Reprocessed Aquamantys Bipolar Sealer | Green Or, LLC | 2022 | — |
| +1 | K121290 | AQUAMANTRYS3 BSC 9.1S | Medtronic, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1995 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K052859 | Aquamantys Pump Generator SystemSummary page 1…y TissueLink) Aquamantys Pump Generator System (includes Aquamantys Pump Generator, Aquamantys 6.0 Bipolar Sealer and Aquamantys 2.3 Bipolar Sealer), K052859 * ValleyLab ForceFX Electrosurgical Generator, K944602 * ValleyLab E25 16 Electrosurgical Pencil, K813071 4. D… | 2005 |
| * | K944602 | Valleylab Force FXSummary page 1…ludes Aquamantys Pump Generator, Aquamantys 6.0 Bipolar Sealer and Aquamantys 2.3 Bipolar Sealer), K052859 * ValleyLab ForceFX Electrosurgical Generator, K944602 * ValleyLab E25 16 Electrosurgical Pencil, K813071 4. DEVICE DESCRIPTION The Salient Surgical Aquamnantys3 Pu… | 1995 |
| * | K813071 | E2508 Disposable Handswitching PencilSummary page 1…ler and Aquamantys 2.3 Bipolar Sealer), K052859 * ValleyLab ForceFX Electrosurgical Generator, K944602 * ValleyLab E25 16 Electrosurgical Pencil, K813071 4. DEVICE DESCRIPTION The Salient Surgical Aquamnantys3 Pump Generator System is a general reference term used… | 1981 |
What descends from it? (3)
3 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 |
|---|---|---|---|---|
| Nov 12, 2013 | Class II | Z-0905-2014 | Device Design | The internal protection circuitry on the electrosurgical output that prevents a patient from exposure to DC voltage when the device is activated is being compromised during normal use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K120537 (Medtronic, Inc., 2012) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K052859.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Aquamantys3 Generator is an electrosurgical generator with monopolar and bipolar RF outputs. It is intended to be used with specified disposables for delivery of RF energy for cutting of soft tissue and RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone at the operative site during surgical procedures. The system is not intended for contraceptive tubal coagulation (permanent female sterilization). The…
Read the full statement (209 words)
The Aquamantys3 Generator is an electrosurgical generator with monopolar and bipolar RF outputs. It is intended to be used with specified disposables for delivery of RF energy for cutting of soft tissue and RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone at the operative site during surgical procedures. The system is not intended for contraceptive tubal coagulation (permanent female sterilization).
The Aquamantys3 Bipolar Sealer is a bipolar, single use, sterile, disposable device intended for use with the Aquamantys3 Generator. The device delivers bipolar RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone. It is intended for, but not limited to, orthopaedic, spine, thoracic, and open abdominal surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
The Aquamantys3 8.2L Bipolar Sealer with Cutting is a monopolar/bipolar, single use, sterile, disposable device intended for use with the Aquamantys3 Generator. The device delivers monopolar RF energy for cutting of soft tissue and bipolar RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone. It is intended for, but not limited to, orthopaedic, spine, thoracic, and open abdominal surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
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/K111285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111285: Aquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer with Cutting.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111285
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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