Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KQX — Predicate Candidate Screening
33 FDA 510(k) clearances under this product code; the 50 most recent screened below.
96 daysmedian FDA review time
272 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011827 | ORTELIUS 800 | Orthoscan , Ltd. | 2001-08-28 | 77 | 0 |
| K971079 | INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE | Interlogics, Inc. | 1997-07-09 | 106 | 0 |
| K962377 | 3D-SPINE | Skill Technologies, Inc. | 1996-09-03 | 75 | 0 |
| K961212 | SPINAL TOUCH | Fasstech | 1996-06-12 | 76 | 0 |
| K954647 | INCLINOMETER | J-Tech, Inc. | 1995-10-30 | 20 | 0 |
| K943929 | DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS) | Greenleaf Medical Systems, Inc. | 1995-05-15 | 276 | 0 |
| K945630 | LARGE MUSCLE STRENGTH GAUGE | J-Tech, Inc. | 1995-05-10 | 175 | 0 |
| K943898 | SAUNDERS ELECTRONIC INCLINOMETER | The Saunders Group | 1994-11-28 | 110 | 0 |
| K940812 | INSIGHT ELECTRONIC ALIGNMENT INDICATOR | Andronic Devices, Ltd. | 1994-11-21 | 272 | 0 |
| K925225 | THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK | Baltimore Therapeutic Equipment Co. | 1994-06-27 | 619 | 0 |
| K933063 | ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA | Isotechnologies, Inc. | 1994-01-27 | 219 | 0 |
| K924416 | BOOST, MICE, GAMESYS. | Penny and Giles Biometrics , Ltd. | 1993-06-15 | 288 | 0 |
| K922550 | ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM) | Verimed Holdings, Inc. | 1992-12-10 | 195 | 0 |
| K920256 | SPINE MOTION ANALYZER WITH EMG | Orthopedic Systems, Inc. | 1992-08-10 | 202 | 0 |
| K920690 | NOROTRACK 360 INCLINOMETER | Noromed, Inc. | 1992-05-20 | 96 | 0 |
| K914060 | RANGE OF MOTION SENSOR, MODEL RM001 | Nk Biotechnical Engineering Co. | 1991-12-09 | 90 | 0 |
| K914061 | NK RANGE OF MOTION SENSOR, MODEL RM002 | Nk Biotechnical Engineering Co. | 1991-12-09 | 90 | 0 |
| K914062 | NK DEXTERITLY BOARD, MODEL BX001 | Nk Biotechnical Engineering Co. | 1991-12-09 | 90 | 0 |
| K913079 | 02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360 | Lucas Sensing Systems, Inc. | 1991-09-25 | 76 | 0 |
| K897178 | DYNATRON 360 RANGE OF MOTION TESTING DEVICE | Dynatronics Corp. | 1990-04-18 | 112 | 0 |
| K894283 | COMPREHENSIVE SPINE MOTION ANALYZER | Orthopedic Systems, Inc. | 1990-01-19 | 210 | 0 |
| K893903 | KRONAMAX KUBE | Physicians Digital Co. | 1989-11-29 | 183 | 0 |
| K893455 | THE HANDSCAN SYSTEM | Digital Body Systems, Inc. | 1989-08-30 | 119 | 0 |
| K884723 | (DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM | Greenleaf Medical Systems, Inc. | 1989-02-08 | 90 | 0 |
| K884611 | THE ORTHORANGER II ELECTRONIC GONIOMETER | Medical Instruments Technology, Inc. | 1989-01-31 | 88 | 0 |
| K884003 | GONIOMETER AND BIOMEDICAL RECORDER SYSTEM | Penny & Giles Blackwood , Ltd. | 1988-12-19 | 89 | 0 |
| K873599 | EDI 320 | Cybex | 1987-10-16 | 42 | 0 |
| K862128 | DIGITAL ELECTRONIC MYO-GRAPH (MUSCLE ANALYZER) | Health Products, Inc. | 1986-07-11 | 37 | 0 |
| K852390 | CMT 1000 | Prestigeline, Inc. | 1985-07-19 | 44 | 0 |
| K832991 | HYPAL ADHESIVE TAPE | Smith & Nephew, Inc. | 1984-01-30 | 150 | 0 |
| K831040 | LAMOREUX-OSI ELECTROGONIOMETER | Orthopedic Systems, Inc. | 1983-07-12 | 103 | 0 |
| K812908 | ELECTRO-GONIOMETER | Chattanooga Group, Inc. | 1981-11-24 | 36 | 0 |
| K810640 | POLARISED LIGHT GRONIOMETER | Cairco , Ltd. | 1981-04-17 | 38 | 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