510(k) Report

FDA applicant

Aerin Medical, Inc.

Sunnyvale, CA10 decisions2015–20261 recall

FDA records 10 decisions for Aerin Medical, Inc. (Sunnyvale, CA) from 2015 to 2026: 10 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 7 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Aerin Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2015: 12016: 12017: 22019: 12020: 12022: 12024: 22026 (partial year): 1
2015high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2015high 1 (2024) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Aerin Medical, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aerin Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories9decisions
  • BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)1decision

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 90 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 105 days; 6 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K162810InSeca ARC Stylus, Aerin ConsoleAerin Medical, Inc. · 20174cite it
  • K221907RhinAer® Stylus (FG1393)Aerin Medical, Inc. · 20222cite it
  • K150637Aerin Medical Wand Model FG011Aerin Medical, Inc. · 20151cites it
  • K192471RHIN1 StylusAerin Medical, Inc. · 20191cites it
  • K161994Aerin Medical StylusAerin Medical, Inc. · 20161cites it
  • K172529Vivaer ARC StylusAerin Medical, Inc. · 20171cites it

What has FDA decided for it lately?

  • K260522RhinAer+ StylusAerin Medical, Inc. · 2026
  • K242630Aerin ConsoleAerin Medical, Inc. · 2024
  • K240253Reach NeedleAerin Medical, Inc. · 2024
  • K221907RhinAer® Stylus (FG1393)Aerin Medical, Inc. · 2022
  • K200300VivAer StylusAerin Medical, Inc. · 20201 recall
  • K192471RHIN1 StylusAerin Medical, Inc. · 2019
  • K172529Vivaer ARC StylusAerin Medical, Inc. · 2017
  • K162810InSeca ARC Stylus, Aerin ConsoleAerin Medical, Inc. · 2017

All 10 as Aerin Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K200300Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack)…Nov 12, 2024Class II