Echosens: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Echosens” (first 2013, latest 2023), across 1 product code in 1 review panel. Median 510(k) review time under this name: 58 days. Since 2017 the median was 58 days, against 121 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 | 116 |
| 2014 | 0 | — |
| 2015 | 2 | 134 |
| 2016 | 1 | 22 |
| 2017 | 2 | 52 |
| 2018 | 1 | 27 |
| 2019 | 0 | — |
| 2020 | 1 | 126 |
| 2021 | 2 | 84 |
| 2022 | 0 | — |
| 2023 | 1 | 64 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Echosens took a median 58 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 121 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 11 | 11 |
Review panels
- Radiology (11)
Most recent Echosens 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223902 | FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) | IYO | 2023-03-02 | 64 |
| K212035 | FibroScan 230 | IYO | 2021-07-30 | 30 |
| K203273 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) | IYO | 2021-03-25 | 139 |
| K200655 | FibroScan® 630 | IYO | 2020-07-16 | 126 |
| K181547 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | IYO | 2018-07-09 | 27 |
| K173034 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | IYO | 2017-11-14 | 47 |
| K172142 | FibroScan 430 Mini+ | IYO | 2017-09-13 | 58 |
| K160524 | FibroScan 530 Compact | IYO | 2016-03-18 | 22 |
| K150239 | FibroScan | IYO | 2015-09-01 | 211 |
| K150949 | FibroScan | IYO | 2015-06-03 | 56 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Echosens.
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 Echosens is the lead sponsor of 10 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT07400289: Development of a FibroScan Liver Examination Using a Single Probe (Recruiting, started 2025-11-14)
- NCT06877026: FibroScan-Reproducibility and Repeatability Study (Completed, started 2025-07-16)
- NCT06519331: Development of a New Method for Liver Stiffness Measurement Using FibroScan (Recruiting, started 2024-11-08)
- NCT05567328: Validation of the New Vibration-guided FibroScan Examination (Completed, started 2022-10-26)
- NCT04747457: Development of Predictive Indicators of Homogeneous Propagation of Ultrasound and Elastic Waves During VCTE Examination (Completed, started 2021-04-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Echosens?
FDA lists 11 510(k) clearances under the applicant name “Echosens” (first 2013, latest 2023), across 1 product code 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 Echosens?
The median time from FDA receipt to decision across 510(k)s cleared under the name Echosens is 58 days. Since 2017: 58 days, versus 121 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Echosens?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 11).
Next steps
- See all 11 Echosens clearances with predicates and recalls
- Run predicate analysis for product code IYO, Echosens'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.