510(k) · Cleared
ClearedAerin Medical 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 Sep 22, 2016 as substantially equivalent to K150637 (Aerin Medical, Inc., 2015) after a 65-day review. Its family tree reaches back 2 generations to 2000. 10 later devices descend from it.
- Decided
- Sep 22, 2016
- Review
- 65 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000778 (2000). 10 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK000778 Entec Reflex Wand 55, Model E4055-01, E4045-01Arthrocare Corp. · 2000
- 1 generation backK150637 Aerin Medical Wand Model FG011Aerin Medical, Inc. · 2015
- This deviceK161994 Aerin Medical StylusAerin Medical, Inc. · 2016
- Descendant · cites it directly · 9 of its ownK162810 InSeca ARC Stylus, Aerin ConsoleAerin Medical, Inc. · 2017
- Descendant · 2 generations on · 4 of its ownK192471 RHIN1 StylusAerin Medical, Inc. · 2019
- Descendant · 3 generations on · 3 of its ownK212666 Neuromark SystemNeurent Medical · 2021
- Descendant · 4 generations on · 2 of its ownK222032 NEUROMARK SystemNeurent Medical · 2022
- Descendant · 5 generations on · 1 of its ownK250048 NEUROMARK System (NMK00301)Neurent Medical, Ltd. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K162810InSeca ARC Stylus, Aerin ConsoleAerin Medical, Inc. · 2017 · cites it directly9descendants
- K192471RHIN1 StylusAerin Medical, Inc. · 2019 · 2 generations on4descendants
- K212666Neuromark SystemNeurent Medical · 2021 · 3 generations on3descendants
- K222032NEUROMARK SystemNeurent Medical · 2022 · 4 generations on2descendants
- K250048NEUROMARK System (NMK00301)Neurent Medical, Ltd. · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000778 | Entec Reflex Wand 55, Model E4055-01, E4045-01 | Arthrocare Corp. | 2000 | — |
| −1 | K150637 | Aerin Medical Wand Model FG011 | Aerin Medical, Inc. | 2015 | — |
| 0 (this device) | K161994 | Aerin Medical Stylus | Aerin Medical, Inc. | 2016 | — |
| +1 | K162810 | InSeca ARC Stylus, Aerin Console | Aerin Medical, Inc. | 2017 | — |
| +2 | K192471 | RHIN1 Stylus | Aerin Medical, Inc. | 2019 | — |
| +3 | K212666 | Neuromark System | Neurent Medical | 2021 | — |
| +4 | K222032 | NEUROMARK System | Neurent Medical | 2022 | — |
| +5 | K250048 | NEUROMARK System (NMK00301) | Neurent Medical, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K150637 | Aerin Medical Wand Model FG011Summary page 4…Class II Product Code: GEI CFR Section: 21 CFR 878.4400 Predicate Device: Aerin Medical Wand (K150637) Device Description The Aerin Medical Stylus is a handheld bipolar radiofrequency (RF) probe designed for… | 2015 |
| † | K993854 | Ora-50 S Autotemp Electrothermal Spine System and Accessories | 1999 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162810 | InSeca ARC Stylus, Aerin Console | 2017 | 9 |
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 16 years and passes through 2 companies; a new generation was cleared every 15.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K162810 (Aerin Medical, Inc., 2017) has gone furthest, with 9 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Aerin Medical 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.
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/K161994 · printed Nov 4, 2026
Cite this page
510(k) Report. “K161994: Aerin Medical Stylus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161994
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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