510(k) · Cleared
Recalled · 2011Aquamantys Pump Generator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tissuelink Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 25, 2005 as substantially equivalent to K024059 (Soring GmbH Medizintechnik, 2003) and 3 other predicates after a 14-day review. Its family tree reaches back 3 generations to 1996. 24 later devices descend from it. It has been recalled once.
- Decided
- Oct 25, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 3 generations to K954171 (1996). 6 ancestors in all. 24 later devices descend from it, 10 citing it directly.
- Root · 3 generations backK954171 Arco-MBC, Arco MCHoll Meditronics, Inc. · 1996
- 2 generations backK993265 Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600Soring GmbH Medizintechnik · 1999
- 1 generation backK024059 MBC SeriesSoring GmbH Medizintechnik · 2003
- This deviceK052859 Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 2005
- Descendant · cites it directly · 7 of its ownK063639 Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Tissuelink Medical, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK111732 Aquamantys SBS 5.0 Sheated Biopolar SealerSalient Surgical Technologies, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK132974 Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini…Medtronic Advanced Energy, LLC · 2013
- Descendant · cites it directly · 4 of its ownK130110 Meddusa Bipolar SystemElliquence, LLC · 2013
- Descendant · 2 generations on · 3 of its ownK190336 Soniquence Bipolar ElectrodesSoniquence, LLC · 2019
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K063639Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Tissuelink Medical, Inc. · 2007 · cites it directly7descendants
- K111732Aquamantys SBS 5.0 Sheated Biopolar SealerSalient Surgical Technologies, Inc. · 2011 · cites it directly5descendants
- K132974Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein…Medtronic Advanced Energy, LLC · 2013 · cites it directly4descendants
- K130110Meddusa Bipolar SystemElliquence, LLC · 2013 · cites it directly4descendants
- K190336Soniquence Bipolar ElectrodesSoniquence, LLC · 2019 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954171 | Arco-MBC, Arco MC | Holl Meditronics, Inc. | 1996 | — |
| −2 | K993265 | Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600 | Soring GmbH Medizintechnik | 1999 | — |
| −1 | K024059 | MBC Series | Soring GmbH Medizintechnik | 2003 | — |
| 0 (this device) | K052859 | Aquamantys Pump Generator System | Tissuelink Medical, Inc. | 2005 | — |
| +1 | K063639 | Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1 | Tissuelink Medical, Inc. | 2007 | — |
| +1 | K111732 | Aquamantys SBS 5.0 Sheated Biopolar Sealer | Salient Surgical Technologies, Inc. | 2011 | — |
| +1 | K132974 | Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4… | Medtronic Advanced Energy, LLC | 2013 | — |
| +1 | K130110 | Meddusa Bipolar System | Elliquence, LLC | 2013 | — |
| +2 | K190336 | Soniquence Bipolar Electrodes | Soniquence, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 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 |
|---|---|---|---|
| * | K024059 | MBC SeriesSummary page 1…Substantial Equivalence of the Aquamantys Pump Generator System is made to: Name: Sdring Gmnbf MBCIM Series 510(k) Number K#024059 Regulation Number 878-4400 Device, Electrosurgical, Cutting & Coagulation & Accessories Product Code… | 2003 |
| * | K020574 | Tissuelink Bipolar Floating Ball Device | 2002 |
| * | K022532 | Tissuelink Bipolar Floating Ball DeviceSummary page 1…Date January 8, 2003 Claim of Substantial Equivalence of the Aquamantys 6.0 and 2.3 Bipolar Sealer devices are made to: TissueLink BPS 6.0 K20574 and K022532 TissucLink BPS 2.3 K032132 TissueLink Medical, Inc.… | 2003 |
| * | K032132 | Tissuelink Floating Ball Model 23-201-1Summary page 1…ary 8, 2003 Claim of Substantial Equivalence of the Aquamantys 6.0 and 2.3 Bipolar Sealer devices are made to: TissueLink BPS 6.0 K20574 and K022532 TissucLink BPS 2.3 K032132 TissueLink Medical, Inc. xx S… | 2003 |
What descends from it? (24)
See all 2410 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063639 | Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1 | 2007 | 7 |
| K111732 | Aquamantys SBS 5.0 Sheated Biopolar Sealer | 2011 | 5 |
| K132974 | Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein… | 2013 | 4 |
| K130110 | Meddusa Bipolar System | 2013 | 4 |
| K111285 | Aquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer with Cutting | 2011 | 3 |
| K101057 | Aquamantys Double Cone Bipolar Sealer Model: 23-310-1 | 2011 | 3 |
| K210423 | Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand | 2021 | 2 |
| K073495 | Tissuelink Aquamantys Malleable Bipolar Sealer with Light | 2008 | 2 |
| K143175 | AEx Generator; PlasmaBlade T | 2014 | 1 |
| K092149 | Boss Coagulation Device, Model BOSS1215, Boss Coagulation Device, Angled Access, Model… | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2011 | Not classified | Z-2892-2011 | Nonconforming Material/Component | Insulating material on the shaft of the device may separate and expose the electrical conductor and result in burning the patient skin |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K063639 (Tissuelink Medical, Inc., 2007) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K024059.
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 Aquamantys™ Bipolar Pump Generator is an electrosurgical generator with a rotary peristaltic pump which is for use only with Aquamantys single-use disposable bipolar devices for concurrent delivery of radiofrequency energy with saline for hemostatic sealing of soft tissue and bone at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, orthopaedic, spine and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
The Aquamantys System is for use only by qualified medical personnel properly trained in the use of electrosurgical equipment, technology and techniques.
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/K052859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052859: Aquamantys Pump Generator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052859
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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