Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LXJ — Predicate Candidate Screening
27 FDA 510(k) clearances under this product code; the 50 most recent screened below.
182 daysmedian FDA review time
339 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192474 | VERA | Reflexion Health, Inc. | 2019-10-10 | 30 | 0 |
| K182333 | Vera | Reflexion Health, Inc. | 2019-04-09 | 224 | 0 |
| K180880 | DARI Health | Scientific Analytics, Inc. | 2019-03-07 | 338 | 0 |
| K171547 | Qualisys Clinical System | Qualisys AB | 2018-08-02 | 433 | 0 |
| K173931 | MindMotion(TM) GO | Mindmaze SA | 2018-05-17 | 142 | 0 |
| K172882 | UINCARE HOME | Uincare Corp. | 2018-05-10 | 231 | 0 |
| K162748 | MindMotionPRO | Mindmaze SA | 2017-04-24 | 206 | 0 |
| K163245 | Virtual Occupational Therapy Application (VOTA) | Barron Associates, Inc. | 2017-02-28 | 102 | 0 |
| K151955 | YuGo System | Biogaming , Ltd. | 2016-02-05 | 205 | 0 |
| K150462 | Vera | Reflexion Health, Inc. | 2015-10-30 | 249 | 0 |
| K151446 | Recovr Rehabilitation System | Recovr,Inc | 2015-09-18 | 112 | 0 |
| K143034 | Jintronix | Jintronix, Inc. | 2015-04-22 | 182 | 0 |
| K131660 | SMART (SMART-D, SMART-DX) | Bts S.P.A. | 2014-04-17 | 315 | 0 |
| K130847 | JINTRONIX REHABILITATION SYSTEM (JRS) | Jintronix, Inc. | 2014-02-28 | 339 | 0 |
| K091000 | KNEEKG | Emovi | 2009-10-26 | 201 | 0 |
| K033514 | CODA CX1 MOTION ANALYSIS SYSTEM | Charnwood Dynamics , Ltd. | 2004-01-06 | 61 | 0 |
| K030714 | PEAK MOTUS | Peak Performance Technologies, Inc. | 2003-05-16 | 71 | 0 |
| K982425 | CODA MPX30 MOTION ANALYSIS SYSTEM | Pinsco Inc. Dba B & L Engineering | 1998-10-07 | 86 | 0 |
| K943430 | CERVICAL FUNCTION INDICATOR | Whiplash Analysis, Inc. | 1995-03-13 | 241 | 0 |
| K923033 | THE TRACKER | Epm Information Systems, Inc. | 1993-06-01 | 435 | 0 |
| K924512 | LIDO V-TAK | Loredan Biomedical, Inc. | 1993-05-12 | 250 | 0 |
| K911416 | ELITE SYSTEM | Gfb Intl. Trading, Inc. | 1991-06-06 | 66 | 0 |
| K890076 | ORTHOTRAK | Motion Analysis Corp. | 1989-02-03 | 25 | 0 |
| K890074 | SPINETRAK | Motion Analysis Corp. | 1989-02-03 | 25 | 0 |
| K890075 | FOOTTRAK | Motion Analysis Corp. | 1989-02-03 | 25 | 0 |
| K880631 | 2K-QDA MOTION/GAIT ANALYSIS SYSTEM | Human Performance Technologies, Inc. | 1988-04-21 | 65 | 0 |
| K811172 | VICON | Oxford Medilog, Inc. | 1981-06-16 | 49 | 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