510(k) · Cleared
ClearedAVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aventix Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 27, 2026 as substantially equivalent to K221907 (Aerin Medical, Inc., 2022) and 1 other predicate after a 58-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Mar 27, 2026
- Review
- 58 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K000778 (2000). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK000778 Entec Reflex Wand 55, Model E4055-01, E4045-01Arthrocare Corp. · 2000
- 3 generations backK150637 Aerin Medical Wand Model FG011Aerin Medical, Inc. · 2015
- 2 generations backK161994 Aerin Medical StylusAerin Medical, Inc. · 2016
- 1 generation backK162810 InSeca ARC Stylus, Aerin ConsoleAerin Medical, Inc. · 2017
- This deviceK260255 AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)Aventix Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000778 | Entec Reflex Wand 55, Model E4055-01, E4045-01 | Arthrocare Corp. | 2000 | — |
| −3 | K150637 | Aerin Medical Wand Model FG011 | Aerin Medical, Inc. | 2015 | — |
| −2 | K161994 | Aerin Medical Stylus | Aerin Medical, Inc. | 2016 | — |
| −1 | K162810 | InSeca ARC Stylus, Aerin Console | Aerin Medical, Inc. | 2017 | — |
| 0 (this device) | K260255 | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) | Aventix Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K221907 | RhinAer® Stylus (FG1393)Summary page 6…ystem and the NOVOCLEAR™ Device K260255 [807.92(a)(3)] Legally Marketed Devices Primary Predicate Device: Aerin Medical Inc. / RhinAer® Stylus (K221907) Secondary Predicate: Aerin Medical Inc. / Aerin Console (K162810) [807.92(a)(4)] Device Description Device Des… | 2022 |
| * | K162810 | InSeca ARC Stylus, Aerin ConsoleSummary page 6…egally Marketed Devices Primary Predicate Device: Aerin Medical Inc. / RhinAer® Stylus (K221907) Secondary Predicate: Aerin Medical Inc. / Aerin Console (K162810) [807.92(a)(4)] Device Description Device Description: The AVENTIX™ PFX System and NOVOCLEAR™ Device… | 2017 |
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 26 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K221907.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 AVENTIX™ PFX System is an electrosurgical system intended to generate Pulsed Field Energy (PFE) for use with the NOVOCLEAR™ Device. The AVENTIX™ PFX System is indicated for use in small clinics, offices and/or hospital environments.
The NOVOCLEAR™ Device is indicated for use in otorhinolaryngology (ENT) surgery for the destruction of soft tissue in the nasal airway, including the posterior nasal nerve distribution in patients with chronic rhinitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260255: AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260255
Report an extraction error
Are you the manufacturer?
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