Medical Device Manufacturer · US , San Jose , CA

Spirair, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2023

Recent clearances: SeptAlign, TurbAlign, SeptAlign

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Spirair, Inc. Ear, Nose, Throat ✕

5 devices

1-5 of 5

Cleared Jul 30, 2026

SeptAlign (SPLN001)

Ear, Nose, Throat · 155d

Cleared Jan 16, 2026

Ear, Nose, Throat · 219d

Cleared Jul 11, 2025

Ear, Nose, Throat · 227d

Cleared Mar 22, 2024

Ear, Nose, Throat · 137d

Cleared Aug 17, 2023

Spirair Nasal Septal Strap

Ear, Nose, Throat · 314d