Claronav, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Claronav, Inc.” (first 2016, latest 2025), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 266 days. Since 2017 the median was 267 days, against 127 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 111 |
| 2017 | 1 | 267 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 454 |
| 2023 | 0 | — |
| 2024 | 1 | 262 |
| 2025 | 2 | 268 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Claronav, Inc. took a median 267 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PLV | Dental Stereotaxic Instrument | 3 | 3 |
| HAW | Neurological Stereotaxic Instrument | 2 | 2 |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | 1 | 1 |
Review panels
- Dental (3)
- Neurology (2)
- Ear, Nose and Throat (1)
Most recent Claronav, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC) | PGW | 2025-06-20 | 266 |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), Cranial | HAW | 2025-02-05 | 271 |
| K233563 | Navident | PLV | 2024-07-25 | 262 |
| K210947 | Navident | PLV | 2022-06-27 | 454 |
| K163439 | NaviENT | HAW | 2017-09-01 | 267 |
| K161406 | Navident | PLV | 2016-09-08 | 111 |
Recalls
openFDA lists no recalls under a recalling firm named Claronav, Inc..
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 Claronav, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Claronav, Inc.” (first 2016, latest 2025), across 3 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 Claronav, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Claronav, Inc. is 266 days. Since 2017: 267 days, versus 127 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Claronav, Inc.?
The most frequent FDA product codes under this applicant name are PLV (Dental Stereotaxic Instrument, 3); HAW (Neurological Stereotaxic Instrument, 2); PGW (Ear, Nose, And Throat Stereotaxic Instrument, 1).
Next steps
- See all 6 Claronav, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PLV, Claronav, 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.