510(k) · Cleared
Recalled · Class II · 2024VivAer Stylus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aerin Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 13, 2020 as substantially equivalent to K172529 (Aerin Medical, Inc., 2017) after a 67-day review. Its family tree reaches back 5 generations to 2000. It has been recalled once.
- Decided
- Apr 13, 2020
- Review
- 67 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K000778 (2000). No later device cites it as a predicate yet.
- Root · 5 generations backK000778 Entec Reflex Wand 55, Model E4055-01, E4045-01Arthrocare Corp. · 2000
- 4 generations backK150637 Aerin Medical Wand Model FG011Aerin Medical, Inc. · 2015
- 3 generations backK161994 Aerin Medical StylusAerin Medical, Inc. · 2016
- 2 generations backK162810 InSeca ARC Stylus, Aerin ConsoleAerin Medical, Inc. · 2017
- 1 generation backK172529 Vivaer ARC StylusAerin Medical, Inc. · 2017
- This deviceK200300 VivAer StylusAerin Medical, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000778 | Entec Reflex Wand 55, Model E4055-01, E4045-01 | Arthrocare Corp. | 2000 | — |
| −4 | K150637 | Aerin Medical Wand Model FG011 | Aerin Medical, Inc. | 2015 | — |
| −3 | K161994 | Aerin Medical Stylus | Aerin Medical, Inc. | 2016 | — |
| −2 | K162810 | InSeca ARC Stylus, Aerin Console | Aerin Medical, Inc. | 2017 | — |
| −1 | K172529 | Vivaer ARC Stylus | Aerin Medical, Inc. | 2017 | — |
| 0 (this device) | K200300 | VivAer Stylus | Aerin Medical, Inc. | 2020 | — |
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? (1)
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 |
|---|---|---|---|
| * | K172529 | Vivaer ARC StylusSummary page 4…Class: Class II Product Code: GEI CFR Section: 21 CFR 878.4400 Predicate Device: Vivaer® ARC Stylus (K172529) Device Description The VivAer® Stylus is a disposable, handheld device capable of delivering bipolar radiofrequency energy to… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 12, 2024 | Class II | Z-0808-2025 | Under Investigation by firm | Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylus when connected to the Aerin Console. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 VivAer® Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the coagulation of soft tissue in the nasal airway, to treat nasal airway obstruction by shrinking submucosal tissue, including cartilage in the internal nasal valve area.
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/K200300 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200300: VivAer Stylus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200300
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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