Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Echosens — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
139 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223902 | FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+ | Echosens | 2023-03-02 | 64 | 0 |
| K212035 | FibroScan 230 | Echosens | 2021-07-30 | 30 | 0 |
| K203273 | FibroScan® Family of Products (Models: 502 Touch, 530 Compac | Echosens | 2021-03-25 | 139 | 0 |
| K200655 | FibroScan® 630 | Echosens | 2020-07-16 | 126 | 0 |
| K181547 | FibroScan® Family of Products (Models: 502 Touch, 530 Compac | Echosens | 2018-07-09 | 27 | 0 |
| K173034 | FibroScan® Family of Products (Models: 502 Touch, 530 Compac | Echosens | 2017-11-14 | 47 | 0 |
| K172142 | FibroScan 430 Mini+ | Echosens | 2017-09-13 | 58 | 0 |
| K160524 | FibroScan 530 Compact | Echosens | 2016-03-18 | 22 | 0 |
| K150239 | FibroScan | Echosens | 2015-09-01 | 211 | 0 |
| K150949 | FibroScan | Echosens | 2015-06-03 | 56 | 0 |
| K123806 | FIBROSCAN | Echosens | 2013-04-05 | 116 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda