510(k) · Cleared
ClearedAqua Medical RF Vapor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aqua Medical, Inc. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Jun 21, 2019 as substantially equivalent to K060169 (Barrx Medical, Incorporated, 2006) and 1 other predicate after a 182-day review. Its family tree reaches back 17 generations to 1995. 4 later devices descend from it.
- Decided
- Jun 21, 2019
- Review
- 182 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K943450 (1995). 40 ancestors in all, the oldest K800617 (1980). 4 later devices descend from it, 4 citing it directly.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK062723 HALO90 Coagulation CatheterBarrx Medical, Incorporated · 2006
- 2 generations backK083711 Modification to: Halo Coagulation Catheter, Models 32041-18…Barrx Medical, Incorporated · 2009
- 1 generation backK093008 Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated · 2010
- This deviceK183595 Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK211282 Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK213627 RF Vapor SystemAqua Medical, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK241271 Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK251226 Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc. · 2025
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK013139 Stellartech Coagulation SystemStellartech Research Corp. · 2001
- 11 generations backK032062 Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003
- 10 generations backK032452 Modification to: Stellartech Coagulation System, Models 1100C-115 &…Stellartech Research Corp. · 2003
- 9 generations backK032721 Modification to: Stellartech Coagulation System (Models 1100C-115 &…Stellartech Research Corp. · 2003
- 8 generations backK040240 Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2004
- 7 generations backK041383 Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp. · 2004
- 6 generations backK042909 Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp. · 2004
- 5 generations backK050831 Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp. · 2005
- 4 generations backK060169 Barrx Halo Coagulation System, Barrx Halo Coagulation Generator…Barrx Medical, Incorporated · 2006
- 3 generations backK062723 HALO90 Coagulation CatheterBarrx Medical, Incorporated · 2006
- 2 generations backK083711 Modification to: Halo Coagulation Catheter, Models 32041-18…Barrx Medical, Incorporated · 2009
- 1 generation backK093008 Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated · 2010
- This deviceK183595 Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K211282Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2021 · cites it directly3descendants
- K213627RF Vapor SystemAqua Medical, Inc. · 2021 · cites it directly2descendants
- K241271Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc. · 2024 · cites it directly1descendant
- K251226Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K013139 | Stellartech Coagulation System | Stellartech Research Corp. | 2001 | — |
| −11 | K032062 | Stellartech Coagulation System, Models (1100C-115 & 1100C-230) | Stellartech Research Corp. | 2003 | — |
| −10 | K032452 | Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230 | Stellartech Research Corp. | 2003 | — |
| −9 | K032721 | Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2003 | — |
| −8 | K040240 | Stellartech Coagulation System (Models 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2004 | — |
| −7 | K041383 | Stellartech Coagulation System, Models 1100C-115 and 1100C-230 | Stellartech Research Corp. | 2004 | — |
| −6 | K042909 | Stellartech Coagulation System, Models 1100C-115A & 1100C-230A | Stellartech Research Corp. | 2004 | — |
| −5 | K050831 | Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230A | Stellartech Research Corp. | 2005 | — |
| −4 | K060169 | Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx… | Barrx Medical, Incorporated | 2006 | — |
| −3 | K062723 | HALO90 Coagulation Catheter | Barrx Medical, Incorporated | 2006 | — |
| −2 | K083711 | Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20… | Barrx Medical, Incorporated | 2009 | — |
| −1 | K093008 | Halo Ablation Catheter, Model 90-9100 | Barrx Medical, Incorporated | 2010 | — |
| 0 (this device) | K183595 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | 2019 | — |
| +1 | K211282 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | 2021 | — |
| +1 | K213627 | RF Vapor System | Aqua Medical, Inc. | 2021 | — |
| +1 | K241271 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | 2024 | — |
| +1 | K251226 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 KNS? 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 KNS device
- #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 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 |
|---|---|---|---|
| * | K060169 | Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation…Summary page 4…ation No: 878.4400 Class: 2 Review Panel: General & Plastic Surgery 3. PREDICATE DEVICE Primary predicate: Halo90 System by Barrx Medical, Inc., cleared under K060169 and K093008 4. DEVICE DESCRIPTION The Aqua RF Vapor System uses a catheter to deliver heat to the tissue surface undergoin… | 2006 |
| * | K093008 | Halo Ablation Catheter, Model 90-9100Summary page 4…8.4400 Class: 2 Review Panel: General & Plastic Surgery 3. PREDICATE DEVICE Primary predicate: Halo90 System by Barrx Medical, Inc., cleared under K060169 and K093008 4. DEVICE DESCRIPTION The Aqua RF Vapor System uses a catheter to deliver heat to the tissue surface undergoing treatment.… | 2010 |
What descends from it? (4)
4 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 24 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 1 of the 40 ancestors has a recall of any class.
- Of its descendants, K211282 (Aqua Medical, Inc., 2021) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K060169.
How does its category compare?
All KNS devicesKNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KNS
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNS
14in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNS
1,504in 2025
MAUDE reports naming product code KNS, 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 | 1 | — | 3 | 164 |
| 2008 | 3 | 61 | 5 | 587 |
| 2009 | 3 | 212 | 2 | 1,027 |
| 2010 | 4 | 168 | 0 | 908 |
| 2011 | 1 | — | 2 | 860 |
| 2012 | 2 | — | 0 | 848 |
| 2013 | 2 | — | 0 | 449 |
| 2014 | 1 | — | 0 | 405 |
| 2015 | 3 | 252 | 0 | 406 |
| 2016 | 3 | 30 | 6 | 457 |
| 2017 | 3 | 48 | 1 | 446 |
| 2018 | 5 | 62 | 0 | 563 |
| 2019 | 7 | 66 | 0 | 668 |
| 2020 | 4 | 212 | 0 | 906 |
| 2021 | 4 | 139 | 41 | 814 |
| 2022 | 3 | 182 | 0 | 913 |
| 2023 | 9 | 83 | 0 | 976 |
| 2024 | 3 | 198 | 14 | 1,533 |
| 2025 | 11 | 171 | 0 | 1,504 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
The Aqua Medical RF Vapor System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus.
Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett’s Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP). The device is to be used in adults only
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/K183595 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183595: Aqua Medical RF Vapor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183595
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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