Sonendo, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Sonendo, Inc.” (first 2013, latest 2021), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 88 days. Since 2017 the median was 74 days, against 119 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 |
|---|---|---|
| 2013 | 1 | 159 |
| 2014 | 1 | 157 |
| 2015 | 1 | 150 |
| 2016 | 2 | 76 |
| 2017 | 0 | — |
| 2018 | 1 | 96 |
| 2019 | 1 | 29 |
| 2020 | 0 | — |
| 2021 | 2 | 74 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sonendo, Inc. took a median 74 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | 7 | 7 |
| KIF | Resin, Root Canal Filling | 2 | 2 |
Review panels
- Dental (9)
Most recent Sonendo, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211995 | Sonendo Filling Material 5C | KIF | 2021-08-27 | 60 |
| K203302 | GentleWave X | ELC | 2021-02-05 | 88 |
| K190359 | Sonendo GentleWave System | ELC | 2019-03-16 | 29 |
| K181922 | Sonendo Material A | KIF | 2018-10-22 | 96 |
| K160905 | Sonendo GentleWave System | ELC | 2016-06-03 | 63 |
| K153157 | Sonendo Gentle Wave System | ELC | 2016-01-29 | 88 |
| K143448 | Sonendo GentleWave System | ELC | 2015-05-01 | 150 |
| K133752 | SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT | ELC | 2014-05-15 | 157 |
| K130025 | SONENDO ENDOTHERAPY SYSTEM | ELC | 2013-06-11 | 159 |
Recalls
3 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2022-10-14.
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.
Device clinical trials
An industry sponsor named Sonendo, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02557152: The GentleWave Registry (Completed, started 2015-09)
- NCT02285595: Sonendo GentleWave™ System for Treatment in Molar Teeth Requiring Root Canal Therapy (Completed, started 2014-07)
SEC filings
Sonendo, Inc. (SONX): EDGAR filings, CIK 1407973. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sonendo, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Sonendo, Inc.” (first 2013, latest 2021), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sonendo, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sonendo, Inc. is 88 days. Since 2017: 74 days, versus 119 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sonendo, Inc.?
The most frequent FDA product codes under this applicant name are ELC (Scaler, Ultrasonic, 7); KIF (Resin, Root Canal Filling, 2).
Next steps
- See all 9 Sonendo, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ELC, Sonendo, 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.