Acclarent, Inc.
FDA Regulatory Profile
Acclarent, Inc. appears in FDA public data with 13 recalls, 45 510(k) clearances, 4 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-0127-2024, Class II) was initiated on September 21, 2023. Its most recent 510(k) clearance was granted on February 19, 2026.
Summary
- Total Recalls
- 13
- 510(k) Clearances
- 45
- Inspections
- 4
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0127-2024 | Class II | TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: | September 21, 2023 |
| Z-0415-2022 | Class II | TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF | November 12, 2021 |
| Z-0825-2020 | Class II | TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884 | March 6, 2019 |
| Z-0824-2020 | Class II | TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877 | March 6, 2019 |
| Z-0826-2020 | Class II | TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891 | March 6, 2019 |
| Z-1740-2015 | Class III | RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - | April 28, 2015 |
| Z-1864-2013 | Class II | Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway t | January 11, 2013 |
| Z-1865-2013 | Class II | Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway t | January 11, 2013 |
| Z-1861-2013 | Class II | Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway t | January 11, 2013 |
| Z-1860-2013 | Class II | Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway t | January 11, 2013 |
| Z-1866-2013 | Class II | Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway t | January 11, 2013 |
| Z-1863-2013 | Class II | Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway t | January 11, 2013 |
| Z-1862-2013 | Class II | Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway | January 11, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System | February 19, 2026 |
| K230742 | ACCLARENT AERA Eustachian Tube Dilation System | December 13, 2023 |
| K231862 | TruDi® Navigation System V3 (FG-2000-00) | July 21, 2023 |
| K221037 | TruDi Shaver Blade | July 20, 2022 |
| K201115 | Next Generation Balloon Dilation System | August 27, 2020 |
| K201174 | TruDi Curette | August 12, 2020 |
| K193453 | TruDi Probe | March 23, 2020 |
| K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter | May 3, 2019 |
| K190532 | TruDi NAV Wire | May 3, 2019 |
| K183090 | Relieva Tract Balloon Dilation System | April 19, 2019 |
| K180948 | TruDi NAV Suction Instruments | July 20, 2018 |
| K173628 | Acclarent ENT Navigation System | March 10, 2018 |
| K171761 | ACCLARENT AERA Eustachian Tube Balloon Dilation System | January 16, 2018 |
| K171687 | Relieva SpinPlus Nav Balloon Sinuplasty System | September 5, 2017 |
| K161697 | Acclarent NavWire Sinus Navigation Guidewire | October 24, 2016 |
| K161698 | Relieva UltirraNav Sinus Balloon Catheter | October 24, 2016 |
| DEN150056 | Acclarent Aera Eustachian Tube Balloon Dilation System | September 16, 2016 |
| K153341 | Relieva Scout Multi-Sinus Dilation System | February 12, 2016 |
| K150453 | TULA Iontophoresis System with Earset | May 20, 2015 |
| K143541 | Relieva SpinPlus Balloon Sinuplasty System | April 22, 2015 |