INSPIRA AIR BALLOON DILATION SYSTEM— 510(k) K110218

Name: FDA 510(k) clearance K110218
Creator: U.S. Food and Drug Administration
Published: 2011-03-31

Substantially Equivalent

Acclarent, Inc.

FDA 510(k) clearance K110218 for INSPIRA AIR BALLOON DILATION SYSTEM, Substantially Equivalent on 2011-03-31. Applicant: Acclarent, Inc.. Device class: 2.

Clearance details

Applicant: Acclarent, Inc.
Product code: Code KTI
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Date received: 2011-01-25
Decision date: 2011-03-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Rmenlo Park, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Acclarent, Inc.

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K253612 — Acclarent AERA Eustachian Tube Balloon Dilation System2026-02-19
K230742 — ACCLARENT AERA Eustachian Tube Dilation System2023-12-13
K231862 — TruDi® Navigation System V3 (FG-2000-00)2023-07-21
K221037 — TruDi Shaver Blade2022-07-20
K201115 — Next Generation Balloon Dilation System2020-08-27

Adverse events under product code KTI

product code KTI

Malfunction: 642
Total: 642

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K110218

K-number listed on FDA's recall record

Z-1724-2025 — INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.Class II·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·20250404
Z-1860-2013 — Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.Class II·Terminated·Acclarent, Inc.·20130111
Z-1861-2013 — Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.Class II·Terminated·Acclarent, Inc.·20130111
Z-1862-2013 — Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.Class II·Terminated·Acclarent, Inc.·20130111
Z-1863-2013 — Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.Class II·Terminated·Acclarent, Inc.·20130111
Z-1864-2013 — Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.Class II·Terminated·Acclarent, Inc.·20130111
Z-1865-2013 — Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.Class II·Terminated·Acclarent, Inc.·20130111
Z-1866-2013 — Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.Class II·Terminated·Acclarent, Inc.·20130111

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110218.

Data sourced from openFDA. This site is unofficial and independent of the FDA.