# Acclarent, Inc.

- Location (FDA's records): Rmenlo Park, CA
- FDA decisions: 45 (2005–2026): 44 510(k) clearances and 1 De Novo grant
- Product codes: LRC (13), KAM (8), PGW (8), EOB (4), PNZ (4), EGJ (3), ETD (2), KTI (2), QGK (1)
- 510(k) review time since 2016: median 122 days, against 100 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 72 (35 its own); citations of its devices by later devices: 57 (35 its own)
- Recalls linked to its devices: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Entellus Medical, Inc.: 5 (https://510kreport.com/company/entellus-medical)
- Micromedics, Inc.: 4 (https://510kreport.com/company/micromedics)
- Exploramed Nc1, Inc.: 3 (https://510kreport.com/company/exploramed-nc1)
- KARL STORZ Endoscopy-America, Inc.: 3 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Biosense Webster, Inc.: 2 (https://510kreport.com/company/biosense-webster)
- Pollux Endoscopy, Inc.: 2 (https://510kreport.com/company/pollux-endoscopy)
- Medtronic Navigation, Inc.: 2 (https://510kreport.com/company/medtronic-navigation)
- Exmoor Plastics, Ltd.: 2 (https://510kreport.com/company/exmoor-plastics)

## Firms that cite its devices most
- Intuit Medical Products, LLC: 4 (https://510kreport.com/company/intuit-medical-products)
- Entellus Medical, Inc.: 4 (https://510kreport.com/company/entellus-medical)
- M/S. Meril Life Sciences Private Limited: 2 (https://510kreport.com/company/m-s-meril-life-sciences-private)
- Medos International SARL: 2 (https://510kreport.com/company/medos-international)
- Biosense Webster, Inc.: 1 (https://510kreport.com/company/biosense-webster)
- Medtronic Xomed, Inc.: 1 (https://510kreport.com/company/medtronic-xomed)
- Tusker Medical, Inc.: 1 (https://510kreport.com/company/tusker-medical)
- Sinusys Corporation: 1 (https://510kreport.com/company/sinusys)

## Its most-cited devices
- K111254: Relieva Solo Elite Sinus Balloon Catheter (2011), cited by 5
- K073041: Relieva and Relieva Acella Sinus Balloon Catheter (2008), cited by 4
- K071845: Relieva Luma Sinus Illumination System, Model Sis-100A (2007), cited by 4
- K090660: Airway Balloon Catheter Inflation Device (2009), cited by 4
- K111875: Relieva Spin Sinus Dilation System (2011), cited by 4
- K171761: ACCLARENT AERA Eustachian Tube Balloon Dilation System (2018), cited by 4

## Recent decisions
- K253612: Acclarent AERA Eustachian Tube Balloon Dilation System (Feb 19, 2026)
- K230742: ACCLARENT AERA Eustachian Tube Dilation System (Dec 13, 2023)
- K231862: TruDi® Navigation System V3 (FG-2000-00) (Jul 21, 2023)
- K221037: TruDi Shaver Blade (Jul 20, 2022)
- K201115: Next Generation Balloon Dilation System (Aug 27, 2020)
- K201174: TruDi Curette (Aug 12, 2020)
- K193453: TruDi Probe (Mar 23, 2020)
- K190525: RELIEVA ULTIRRA Sinus Balloon Catheter (May 3, 2019)

Source page: https://510kreport.com/company/acclarent