Acclarent, Inc.: FDA filings under this applicant name
FDA lists 44 510(k) clearances under the applicant name “Acclarent, Inc.” (first 2005, latest 2026), plus 1 De Novo decision, across 9 product codes in 3 review panels. Median 510(k) review time under this name: 102 days. Since 2017 the median was 102 days, against 137 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 280 |
| 2013 | 0 | — |
| 2014 | 2 | 146 |
| 2015 | 3 | 89 |
| 2016 | 3 | 126 |
| 2017 | 1 | 90 |
| 2018 | 3 | 106 |
| 2019 | 3 | 60 |
| 2020 | 3 | 103 |
| 2021 | 0 | — |
| 2022 | 1 | 104 |
| 2023 | 2 | 150 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 93 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Acclarent, Inc. took a median 102 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 137 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LRC | Instrument, Ent Manual Surgical | 13 | 13 |
| KAM | Cannula, Sinus | 8 | 8 |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | 8 | 8 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 4 | 4 |
| PNZ | Eustachian Tube Balloon Dilation Device | 4 | 3 |
| EGJ | Device, Iontophoresis, Other Uses | 3 | 3 |
| ETD | Tube, Tympanostomy | 2 | 2 |
| KTI | Bronchoscope Accessory | 2 | 2 |
| QGK | Balloon, Nasal Airway | 1 | 1 |
Review panels
Most recent Acclarent, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System | PNZ | 2026-02-19 | 93 |
| K230742 | ACCLARENT AERA Eustachian Tube Dilation System | PNZ | 2023-12-13 | 271 |
| K231862 | TruDi® Navigation System V3 (FG-2000-00) | PGW | 2023-07-21 | 28 |
| K221037 | TruDi Shaver Blade | PGW | 2022-07-20 | 104 |
| K201115 | Next Generation Balloon Dilation System | LRC | 2020-08-27 | 122 |
| K201174 | TruDi Curette | PGW | 2020-08-12 | 103 |
| K193453 | TruDi Probe | PGW | 2020-03-23 | 101 |
| K190532 | TruDi NAV Wire | PGW | 2019-05-03 | 60 |
| K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter | LRC | 2019-05-03 | 60 |
| K183090 | Relieva Tract Balloon Dilation System | QGK | 2019-04-19 | 164 |
34 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN150056 | De Novo | Eustachian Tube Balloon Dilation Device | 2016-09-16 |
Recalls
15 product recalls in 7 recall events; 2 initiated in the last five years. Most recent: 2023-09-21.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Acclarent, Inc.?
FDA lists 44 510(k) clearances under the applicant name “Acclarent, Inc.” (first 2005, latest 2026), plus 1 De Novo decision, across 9 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Acclarent, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acclarent, Inc. is 102 days. Since 2017: 102 days, versus 137 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Acclarent, Inc.?
The most frequent FDA product codes under this applicant name are LRC (Instrument, Ent Manual Surgical, 13); KAM (Cannula, Sinus, 8); PGW (Ear, Nose, And Throat Stereotaxic Instrument, 8).
Next steps
- See all 44 Acclarent, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LRC, Acclarent, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.