Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MUA — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
222 daysmedian FDA review time
361 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211350 | Bindex BI-2 | Bone Index Finland , Ltd. | 2022-04-29 | 361 | 0 |
| K202514 | EchoS Family | Echolight S.P.A | 2021-02-25 | 178 | 0 |
| K180516 | EchoS | Echolight S.P.A | 2018-10-19 | 234 | 0 |
| K161919 | UltraScan 650 | Cyberlogic, Inc. | 2017-04-05 | 266 | 0 |
| K161971 | Bindex BI-2 | Bone Index Finland , Ltd. | 2017-01-09 | 175 | 0 |
| K152020 | Bindex BI-100 | Bone Index Finland , Ltd. | 2016-05-13 | 297 | 0 |
| K123238 | ACHILLES | Ge Medical Systems China Co., Ltd. | 2013-02-25 | 132 | 0 |
| K110646 | BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER | Beam-Med, Ltd. | 2011-10-12 | 222 | 0 |
| K103633 | ACHILLES | Ge Medical Systems China Co., Ltd. | 2011-05-11 | 149 | 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