510(k) · Cleared
ClearedAqua Medical RF Vapor Ablation 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 Aug 8, 2025 as substantially equivalent to K213627 (Aqua Medical, Inc., 2021) and 3 other predicates after a 109-day review. Its family tree reaches back 21 generations to 1995.
- Decided
- Aug 8, 2025
- Review
- 109 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 21 generations to K943450 (1995). 44 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations between
- 3 generations backK211282 Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2021
- 2 generations backK213627 RF Vapor SystemAqua Medical, Inc. · 2021
- 1 generation backK241271 Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc. · 2024
- This deviceK251226 Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc. · 2025
Show all 21 generations
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 17 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 16 generations backK013139 Stellartech Coagulation SystemStellartech Research Corp. · 2001
- 15 generations backK032062 Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003
- 14 generations backK032452 Modification to: Stellartech Coagulation System, Models 1100C-115 &…Stellartech Research Corp. · 2003
- 13 generations backK032721 Modification to: Stellartech Coagulation System (Models 1100C-115 &…Stellartech Research Corp. · 2003
- 12 generations backK040240 Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2004
- 11 generations backK041383 Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp. · 2004
- 10 generations backK042909 Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp. · 2004
- 9 generations backK050831 Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp. · 2005
- 8 generations backK060169 Barrx Halo Coagulation System, Barrx Halo Coagulation Generator…Barrx Medical, Incorporated · 2006
- 7 generations backK062723 HALO90 Coagulation CatheterBarrx Medical, Incorporated · 2006
- 6 generations backK083711 Modification to: Halo Coagulation Catheter, Models 32041-18…Barrx Medical, Incorporated · 2009
- 5 generations backK093008 Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated · 2010
- 4 generations backK183595 Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2019
- 3 generations backK211282 Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2021
- 2 generations backK213627 RF Vapor SystemAqua Medical, Inc. · 2021
- 1 generation backK241271 Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc. · 2024
- This deviceK251226 Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −20 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −17 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −16 | K013139 | Stellartech Coagulation System | Stellartech Research Corp. | 2001 | — |
| −15 | K032062 | Stellartech Coagulation System, Models (1100C-115 & 1100C-230) | Stellartech Research Corp. | 2003 | — |
| −14 | K032452 | Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230 | Stellartech Research Corp. | 2003 | — |
| −13 | K032721 | Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2003 | — |
| −12 | K040240 | Stellartech Coagulation System (Models 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2004 | — |
| −11 | K041383 | Stellartech Coagulation System, Models 1100C-115 and 1100C-230 | Stellartech Research Corp. | 2004 | — |
| −10 | K042909 | Stellartech Coagulation System, Models 1100C-115A & 1100C-230A | Stellartech Research Corp. | 2004 | — |
| −9 | K050831 | Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230A | Stellartech Research Corp. | 2005 | — |
| −8 | K060169 | Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx… | Barrx Medical, Incorporated | 2006 | — |
| −7 | K062723 | HALO90 Coagulation Catheter | Barrx Medical, Incorporated | 2006 | — |
| −6 | K083711 | Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20… | Barrx Medical, Incorporated | 2009 | — |
| −5 | K093008 | Halo Ablation Catheter, Model 90-9100 | Barrx Medical, Incorporated | 2010 | — |
| −4 | K183595 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | 2019 | — |
| −3 | K211282 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | 2021 | — |
| −2 | K213627 | RF Vapor System | Aqua Medical, Inc. | 2021 | — |
| −1 | K241271 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | 2024 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K213627 | RF Vapor SystemSummary page 5…General & Plastic Surgery 3. PREDICATE DEVICES Primary Predicate: Aqua Medical RF Vapor System, by Aqua Medical Inc., Product code KNS, GEI cleared Under: K213627, K211282, K183595 and K241271. 4. DEVICE DESCRIPTION The Aqua RF Vapor Ablation System is a catheter-based device that uses ra… | 2021 |
| * | K211282 | Aqua Medical RF Vapor SystemSummary page 5…General & Plastic Surgery 3. PREDICATE DEVICES Primary Predicate: Aqua Medical RF Vapor System, by Aqua Medical Inc., Product code KNS, GEI cleared Under: K213627, K211282, K183595 and K241271. 4. DEVICE DESCRIPTION The Aqua RF Vapor Ablation System is a catheter-based device that uses radiofreque… | 2021 |
| * | K183595 | Aqua Medical RF Vapor SystemSummary page 5…l & Plastic Surgery 3. PREDICATE DEVICES Primary Predicate: Aqua Medical RF Vapor System, by Aqua Medical Inc., Product code KNS, GEI cleared Under: K213627, K211282, K183595 and K241271. 4. DEVICE DESCRIPTION The Aqua RF Vapor Ablation System is a catheter-based device that uses radiofrequency (RF)… | 2019 |
| * | K241271 | Aqua Medical RF Vapor Ablation SystemSummary page 5…Surgery 3. PREDICATE DEVICES Primary Predicate: Aqua Medical RF Vapor System, by Aqua Medical Inc., Product code KNS, GEI cleared Under: K213627, K211282, K183595 and K241271. 4. DEVICE DESCRIPTION The Aqua RF Vapor Ablation System is a catheter-based device that uses radiofrequency (RF) energy to pr… | 2024 |
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 30 years and passes through 4 companies; a new generation was cleared every 8 months on median.
- 1 of the 44 ancestors has a recall of any class.
- 1 other device also cites its predicate K213627.
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. 2025, 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 and ablation 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/K251226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251226: Aqua Medical RF Vapor Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251226
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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