FDA product code HOX: Chart, Visual Acuity
HOX is the FDA product code for chart, visual acuity. It is a Class I device, regulated under 21 CFR 886.1150 and reviewed by the Ophthalmic panel. FDA has cleared 32 510(k) submissions under HOX, from 22 different applicants. The average 510(k) review took 64 days (median 62).
Classification
| Field | Value |
|---|---|
| Device name | Chart, Visual Acuity |
| Device class | Class I |
| Regulation | 21 CFR 886.1150 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HOX clearance
Top HOX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vistech Consultants, Inc. | 7 | 1988-07-15 |
| Mentor O & O, Inc. | 3 | 1988-03-08 |
| Stereo Optical Co., Inc. | 2 | 1988-03-17 |
| Richmond Products, Inc. | 2 | 1987-12-11 |
| Vimetrics,Llc. | 1 | 2010-05-10 |
17 more applicants have HOX clearances. See the full list in Caduvo.
Most recent HOX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K100095 | Vimetrics,Llc. | CENTRAL VISION ANALYZER MODEL 1000 | 2010-05-10 | 117 |
| K944156 | Heine USA , Ltd. | HEINE LAMBDA 100 | 1995-01-12 | 139 |
| K881971 | Applied Vision Concepts, Inc. | OCCU-TECH VISION TEST | 1988-11-25 | 198 |
| K883337 | Optimed Technologies, Inc. | PL 20/20 INFANT VISION TESTER | 1988-10-31 | 83 |
| K882634 | Vistech Consultants, Inc. | VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE | 1988-07-15 | 18 |
Recalls for HOX devices
openFDA lists no recalls for product code HOX.
Frequently asked questions
What is FDA product code HOX?
HOX is the FDA product code for chart, visual acuity. It is a Class I device, regulated under 21 CFR 886.1150 and reviewed by the Ophthalmic panel.
What device class is HOX?
Class I, regulation 21 CFR 886.1150. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HOX?
Across 32 cleared submissions the average was 64 days from receipt to decision (median 62).
Which companies have the most HOX clearances?
Vistech Consultants, Inc. (7); Mentor O & O, Inc. (3); Stereo Optical Co., Inc. (2); Richmond Products, Inc. (2); Vimetrics,Llc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HOX
- Run a recall and safety report across every HOX manufacturer
- Watch product code HOX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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