Aerin Medical, Inc.
Mountain View, CA, US
AERIN MEDICAL INC. appears in FDA device records in Mountain View, CA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Aerin Medical, Inc. between 2015 and 2026. The busiest year on record is 2017, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2024 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260522 | RhinAer+ Stylus | GEI | Substantially Equivalent | |
| K242630 | Aerin Console | GEI | Substantially Equivalent | |
| K240253 | Reach Needle | BSP | Substantially Equivalent | |
| K221907 | RhinAer® Stylus (FG1393) | GEI | Substantially Equivalent | |
| K200300 | VivAer Stylus | GEI | Substantially Equivalent | |
| K192471 | RHIN1 Stylus | GEI | Substantially Equivalent | |
| K172529 | Vivaer ARC Stylus | GEI | Substantially Equivalent | |
| K162810 | InSeca ARC Stylus, Aerin Console | GEI | Substantially Equivalent | |
| K161994 | Aerin Medical Stylus | GEI | Substantially Equivalent | |
| K150637 | Aerin Medical Wand Model FG011 | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011625895 | 3011625895 | AERIN MEDICAL INC. | 2565 Leghorn St., Mountain View, CA 94043 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0808-2025 | Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile. | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain