Acclarent Inc
Irvine, CA, US
ACCLARENT, INC. appears in FDA device records in Irvine, CA. FDA records list 45 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 15 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 45 510(k) clearances for Acclarent Inc between 2005 and 2026. The busiest year on record is 2011, with 8. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 4 |
| 2007 | 1 |
| 2008 | 4 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 8 |
| 2012 | 1 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 4 |
| 2017 | 1 |
| 2018 | 3 |
| 2019 | 3 |
| 2020 | 3 |
| 2022 | 1 |
| 2023 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System | PNZ | Substantially Equivalent | |
| K230742 | ACCLARENT AERA Eustachian Tube Dilation System | PNZ | Substantially Equivalent | |
| K231862 | TruDi® Navigation System V3 (FG-2000-00) | PGW | Substantially Equivalent | |
| K221037 | TruDi Shaver Blade | PGW | Substantially Equivalent | |
| K201115 | Next Generation Balloon Dilation System | LRC | Substantially Equivalent | |
| K201174 | TruDi Curette | PGW | Substantially Equivalent | |
| K193453 | TruDi Probe | PGW | Substantially Equivalent | |
| K190532 | TruDi NAV Wire | PGW | Substantially Equivalent | |
| K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter | LRC | Substantially Equivalent | |
| K183090 | Relieva Tract Balloon Dilation System | QGK | Substantially Equivalent | |
| K180948 | TruDi NAV Suction Instruments | PGW | Substantially Equivalent | |
| K173628 | Acclarent ENT Navigation System | PGW | Substantially Equivalent | |
| K171761 | ACCLARENT AERA Eustachian Tube Balloon Dilation System | PNZ | Substantially Equivalent | |
| K171687 | Relieva SpinPlus Nav Balloon Sinuplasty System | LRC | Substantially Equivalent | |
| K161698 | Relieva UltirraNav Sinus Balloon Catheter | LRC | Substantially Equivalent | |
| K161697 | Acclarent NavWire Sinus Navigation Guidewire | PGW | Substantially Equivalent | |
| DEN150056 | Acclarent Aera Eustachian Tube Balloon Dilation System | PNZ | Unknown | |
| K153341 | Relieva Scout Multi-Sinus Dilation System | LRC | Substantially Equivalent | |
| K150453 | TULA Iontophoresis System with Earset | EGJ | Substantially Equivalent | |
| K143541 | Relieva SpinPlus Balloon Sinuplasty System | LRC | Substantially Equivalent | |
| K150172 | ACCLARENT SE Inflation Device | LRC | Substantially Equivalent | |
| K132433 | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE | EOB | Substantially Equivalent | |
| K140160 | RELIEVA SCOUT SINUS DILATION SYSTEM | LRC | Substantially Equivalent | |
| K120280 | RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM | LRC | Substantially Equivalent | |
| K111875 | RELIEVA SPIN SINUS DILATION SYSTEM | LRC | Substantially Equivalent | |
| K110687 | RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) | KAM | Substantially Equivalent | |
| K111254 | RELIEVA SOLO ELITE SINUS BALLOON CATHETER | LRC | Substantially Equivalent | |
| K110636 | TULA IONTOPHORESIS SYSTEM | EGJ | Substantially Equivalent | |
| K110097 | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE | EOB | Substantially Equivalent | |
| K103595 | ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM | ETD | Substantially Equivalent | |
| K110218 | INSPIRA AIR BALLOON DILATION SYSTEM | KTI | Substantially Equivalent | |
| K100577 | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE | EOB | Substantially Equivalent | |
| K093594 | MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER | KAM | Substantially Equivalent | |
| K090660 | AIRWAY BALLOON CATHETER INFLATION DEVICE | KTI | Substantially Equivalent | |
| K083574 | RELIEVA STRATUS MICROFLOW SPACER | KAM | Substantially Equivalent | |
| K082188 | TYMPANOSTOMY TUBE | ETD | Substantially Equivalent | |
| K072891 | SINUS SPACER | KAM | Substantially Equivalent | |
| K073041 | RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER | KAM | Substantially Equivalent | |
| K073276 | IONTOPHORESIS SYSTEM | EGJ | Substantially Equivalent | |
| K071845 | RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A | KAM | Substantially Equivalent | |
| K063078 | MICROENDOSCOPE | EOB | Substantially Equivalent | |
| K062458 | ETHMOID SINUS SPACER | KAM | Substantially Equivalent | |
| K061903 | RELIEVA SINUS BALLOON CATHETER | LRC | Substantially Equivalent | |
| K060974 | RELIENT NAVIGATION DEVICE | KAM | Substantially Equivalent | |
| K052198 | RELIEVA SINUS BALLOON INFLATION DEVICE | LRC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005172759 | 3005172759 | ACCLARENT, INC. | 7585 Irvine Center Dr, Irvine, CA 92618 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QGKBalloon, Nasal Airway
- KTIBronchoscope Accessory
- KAMCannula, Sinus
- EGJDevice, Iontophoresis, Other Uses
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- PGWEar, Nose, And Throat Stereotaxic Instrument
- PNZEustachian Tube Balloon Dilation Device
- LRCInstrument, Ent Manual Surgical
- KARIrrigator, Sinus
- EOBNasopharyngoscope (Flexible Or Rigid)
- EQHSource, Carrier, Fiberoptic Light
- ETDTube, Tympanostomy
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0127-2024 | 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 structural damage. | Class II | Open, Classified | |
| Z-0415-2022 | 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 to optic nerve. | Class II | Open, Classified | |
| Z-0826-2020 | TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891 | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. | Class II | Terminated | |
| Z-0825-2020 | TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884 | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. | Class II | Terminated | |
| Z-0824-2020 | 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. | Class II | Terminated | |
| Z-1740-2015 | 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. | Class III | Terminated | |
| Z-1866-2013 | Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 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. | Class II | Terminated | |
| Z-1865-2013 | Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 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. | Class II | Terminated | |
| Z-1864-2013 | Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 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. | Class II | Terminated | |
| Z-1863-2013 | Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 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. | Class II | Terminated | |
| Z-1862-2013 | Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 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. | Class II | Terminated | |
| Z-1861-2013 | Inspira AIR Balloon Dilation system. Size 7 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. | Class II | Terminated | |
| Z-1860-2013 | 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. | Class II | Terminated | |
| Z-1095-2012 | 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. | Terminated | ||
| Z-0559-06 | 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 Park, CA 94025 | Device sterility may be compromised as evidenced by a loss of package integrity. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain