Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HOX — Predicate Candidate Screening
32 FDA 510(k) clearances under this product code; the 50 most recent screened below.
62 daysmedian FDA review time
106 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100095 | CENTRAL VISION ANALYZER MODEL 1000 | Vimetrics,Llc. | 2010-05-10 | 117 | 0 |
| K944156 | HEINE LAMBDA 100 | Heine USA , Ltd. | 1995-01-12 | 139 | 0 |
| K881971 | OCCU-TECH VISION TEST | Applied Vision Concepts, Inc. | 1988-11-25 | 198 | 0 |
| K883337 | PL 20/20 INFANT VISION TESTER | Optimed Technologies, Inc. | 1988-10-31 | 83 | 0 |
| K882634 | VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE | Vistech Consultants, Inc. | 1988-07-15 | 18 | 0 |
| K881358 | PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM | Neuroscientific Corp. | 1988-06-27 | 88 | 0 |
| K881059 | MCT 8000 (MULTI-VISION CONTRAST TESTER) | Vistech Consultants, Inc. | 1988-04-04 | 24 | 0 |
| K881021 | VCTS 700S SYSTEM | Vistech Consultants, Inc. | 1988-04-01 | 22 | 0 |
| K881023 | VCTS 6500 SYSTEM | Vistech Consultants, Inc. | 1988-04-01 | 22 | 0 |
| K881022 | VCTS MARKETING PROGRAM SYSTEM | Vistech Consultants, Inc. | 1988-04-01 | 22 | 0 |
| K880647 | ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) | Fred Sammons, Inc. | 1988-04-01 | 45 | 0 |
| K875237 | OPTEC 1000 DMV VISION TESTER MODIFY | Stereo Optical Co., Inc. | 1988-03-17 | 86 | 0 |
| K875112 | MENTOR B-VAT(TM) II VIDEO TESTER | Mentor O & O, Inc. | 1988-03-08 | 84 | 0 |
| K873916 | 'E' CUBE AND 'E' PAD | Richmond Products, Inc. | 1987-12-11 | 77 | 0 |
| K873909 | READING CHARTS-CARDS (DISTANCE AND NEARPOINT) | Richmond Products, Inc. | 1987-10-28 | 33 | 0 |
| K863509 | OPTEC 1000 DMV | Stereo Optical Co., Inc. | 1986-11-10 | 62 | 0 |
| K861416 | CANON AUTO ACUITOMETER CV-10 | Canon USA, Inc. | 1986-05-14 | 29 | 0 |
| K854983 | OPTRONICS CONTRAST ACUITY TESTER | Optronics, Inc. | 1986-02-04 | 54 | 0 |
| K854047 | IN-HOME VISION MONITORING KIT | Rich-Larky Company, Inc. | 1985-12-13 | 71 | 0 |
| K853736 | MENTOR BRIGHTNESS ACUITY TESTER | Mentor O & O, Inc. | 1985-11-01 | 56 | 0 |
| K853481 | VISTECH VCTS GLARE TESTER | Vistech Consultants, Inc. | 1985-10-29 | 70 | 0 |
| K840255 | VISTECH VCTS 6000 | Vistech Consultants, Inc. | 1984-04-13 | 81 | 0 |
| K834145 | ERGO DIAGNOSTIC CARD | American Ergo Systems | 1984-03-16 | 106 | 0 |
| K833956 | DOT VISUAL ACVITY TEST 2000 | Good-Lite Co. | 1984-01-04 | 49 | 0 |
| K833778 | TESTING VISUAL ACUITY | Technical Enginuities Co. | 1984-01-04 | 69 | 0 |
| K830011 | VFS 1000/SCREENING FUNCTION ANALYZER | CooperVision, Inc. | 1983-01-17 | 14 | 0 |
| K822215 | NIC OPTRONICS CS-2000 | Nicolet Biomedical Instruments | 1982-08-31 | 36 | 0 |
| K821932 | MENTOR POTENTIAL ACUITY METER | Mentor O & O, Inc. | 1982-08-03 | 35 | 0 |
| K813376 | EYE CHARTS | Abco Dealers, Inc. | 1982-01-07 | 37 | 0 |
| K803256 | EYETECH-VISION SCREENING SYSTEM | Eyedex | 1981-03-04 | 71 | 0 |
| K790909 | OPHTHALMIC DRESSING TRAY | Pent-Cal, Inc. | 1979-08-03 | 81 | 0 |
| K781452 | BAYLOW VISUAL ACUITY TESTER | Codman & Shurtleff, Inc. | 1978-10-24 | 62 | 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