Data / Medical devices / United States / Acclarent, Inc.
Acclarent, Inc.: FDA-registered device maker in Irvine, CA, United States, 20 510(k) clearances
Acclarent, Inc. is registered with the FDA (registration 3005172759) in Irvine, CA, United States. It lists 9 device types. The FDA files 20 510(k) clearances under its listings, the newest dated February 19, 2026. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005172759
- Address
- 7585 Irvine Center Dr, Irvine, CA, United States, 92618
- Owner or operator
- ACCLARENT, INC. (9068915)
- Roles
- Specification developer
- First device listed
- May 20, 2005
- Registered through
- 2026
- Brand names listed
- ACCLARENT PIVOT Balloon Dilation Systems, ACCLARENT SE Inflation Device, Acclarent AERA Eustachian Tube Balloon Dilation System, Acclarent Inflation Device, Acclarent Navwire Sinus Navigation Guidewire, Acclarent Relieva SpinPlus Nav Balloon Sinuplasty System, Acclarent Relieva Ultirra® Nav Sinus Balloon Catheter, Inspira Air Balloon Dilation System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Balloon, Nasal Airway | QGK | 1 | Specification developer | accessdata.fda.gov |
| Bronchoscope Accessory | KTI | 2 | Specification developer | accessdata.fda.gov |
| Cannula, Sinus | KAM | 1 | Specification developer | accessdata.fda.gov |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | 2 | Specification developer | accessdata.fda.gov |
| Ear, Nose, And Throat Stereotaxic Instrument | PGW | 2 | Specification developer | accessdata.fda.gov |
| Eustachian Tube Balloon Dilation Device | PNZ | 2 | Specification developer | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Specification developer | accessdata.fda.gov |
| Irrigator, Sinus | KAR | 1 | Specification developer | accessdata.fda.gov |
| Source, Carrier, Fiberoptic Light | EQH | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 19, 2026 | K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System | PNZ | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| July 21, 2023 | K231862 | TruDi® Navigation System V3 (FG-2000-00) | PGW | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| July 20, 2022 | K221037 | TruDi Shaver Blade | PGW | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| August 27, 2020 | K201115 | Next Generation Balloon Dilation System | LRC | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| August 12, 2020 | K201174 | TruDi Curette | PGW | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| March 23, 2020 | K193453 | TruDi Probe | PGW | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| January 30, 2020 | K192397 | TruDi Navigation System | PGW | Substantially Equivalent | Biosense Webster | accessdata.fda.gov |
| May 3, 2019 | K190532 | TruDi NAV Wire | PGW | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| May 3, 2019 | K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter | LRC | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| April 19, 2019 | K183090 | Relieva Tract Balloon Dilation System | QGK | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| July 20, 2018 | K180948 | TruDi NAV Suction Instruments | PGW | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| September 5, 2017 | K171687 | Relieva SpinPlus Nav Balloon Sinuplasty System | LRC | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| October 24, 2016 | K161698 | Relieva UltirraNav Sinus Balloon Catheter | LRC | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| October 24, 2016 | K161697 | Acclarent NavWire Sinus Navigation Guidewire | PGW | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| February 12, 2016 | K153341 | Relieva Scout Multi-Sinus Dilation System | LRC | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| April 22, 2015 | K143541 | Relieva SpinPlus Balloon Sinuplasty System | LRC | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| April 7, 2015 | K150172 | ACCLARENT SE Inflation Device | LRC | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| March 31, 2011 | K110218 | INSPIRA AIR BALLOON DILATION SYSTEM | KTI | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| September 28, 2007 | K071845 | RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A | KAM | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| August 31, 2005 | K052198 | RELIEVA SINUS BALLOON INFLATION DEVICE | LRC | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 21, 2023 | 93087 | Class II | Ongoing | TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005 | When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and Throat (ENT) and ENT skull base surgery, which may cause delayed/prolonged surgery, cerebrospinal fluid leak, visual impairment, or skull base | accessdata.fda.gov |
| November 12, 2021 | 89170 | Class II | Ongoing | TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z | Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy error, this could lead to an intraprocedural delay, a potential for reversible tissue damage or damage to the carotid artery, CSF leak, or damage | accessdata.fda.gov |
| March 6, 2019 | 84398 | Class II | Terminated | TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877 | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. | accessdata.fda.gov |
| April 28, 2015 | 71232 | Class III | Terminated | RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures.. | Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date. | accessdata.fda.gov |
| January 11, 2013 | 64625 | Class II | Terminated | Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree. | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. | accessdata.fda.gov |
| January 30, 2012 | 61070 | Not yet classified | Terminated | Inspira AIR Balloon Dilation System, size 18 x 40; Manufactured by Acclarent, Inc. 1525-G O'Brien Drive, Menlo Park, CA 94025 Product Usage: Dilation of airway tree. | Acclarent received reports of difficulty deflating the balloon during the procedure, which could potentially result in airway obstruction. | accessdata.fda.gov |
| January 20, 2006 | 34524 | Not yet classified | Terminated | Acclarent brand Relieva Sinus Inflation Device Kit; Model BID30; The kit contains 1 inflation device, 1-10'' extension tube, 1-20cc syringe, 3-way stop-cock; Manufactured for Acclarent, Inc., 1525-B O''Brien Dr., Menlo P | Device sterility may be compromised as evidenced by a loss of package integrity. | accessdata.fda.gov |
Compare with other makers
- All makers of Ear, Nose, And Throat Stereotaxic Instrument
- All makers of Instrument, Ent Manual Surgical
- All makers of Eustachian Tube Balloon Dilation Device
- All makers of Bronchoscope Accessory
- All makers of Cannula, Sinus
- All makers of Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Updated February 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.