# Aerin Medical, Inc.

- Location (FDA's records): Sunnyvale, CA
- FDA decisions: 10 (2015–2026): 10 510(k) clearances
- Product codes: GEI (9), BSP (1)
- 510(k) review time since 2016: median 90 days, against 105 for FDA's reviews in the same codes and years (6 of 9 faster)
- Predicates its devices cite: 9 (7 its own); citations of its devices by later devices: 10 (7 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Arthrocare Corp.: 1 (https://510kreport.com/company/arthrocare)
- Entellus Medical, Inc.: 1 (https://510kreport.com/company/entellus-medical)

## Firms that cite its devices most
- Aventix Medical, Inc.: 2 (https://510kreport.com/company/aventix-medical)
- Neurent Medical: 1 (https://510kreport.com/company/neurent-medical)

## Its most-cited devices
- K162810: InSeca ARC Stylus, Aerin Console (2017), cited by 4
- K221907: RhinAer® Stylus (FG1393) (2022), cited by 2
- K150637: Aerin Medical Wand Model FG011 (2015), cited by 1
- K192471: RHIN1 Stylus (2019), cited by 1
- K161994: Aerin Medical Stylus (2016), cited by 1
- K172529: Vivaer ARC Stylus (2017), cited by 1

## Recent decisions
- K260522: RhinAer+ Stylus (May 18, 2026)
- K242630: Aerin Console (Dec 10, 2024)
- K240253: Reach Needle (Mar 21, 2024)
- K221907: RhinAer® Stylus (FG1393) (Jul 29, 2022)
- K200300: VivAer Stylus (Apr 13, 2020)
- K192471: RHIN1 Stylus (Dec 20, 2019)
- K172529: Vivaer ARC Stylus (Dec 5, 2017)
- K162810: InSeca ARC Stylus, Aerin Console (Jan 11, 2017)

Source page: https://510kreport.com/company/aerin-medical