FDA product code HPG: Aid, Vision, Electronic, Battery-Powered
HPG is the FDA product code for aid, vision, electronic, battery-powered. It is a Class I device, regulated under 21 CFR 886.5900 and reviewed by the Ophthalmic panel. FDA has cleared 7 510(k) submissions under HPG, from 5 different applicants. The average 510(k) review took 73 days (median 86).
Classification
| Field | Value |
|---|---|
| Device name | Aid, Vision, Electronic, Battery-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.5900 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HPG clearance
Top HPG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nurion Industries | 3 | 1991-05-14 |
| Triangle Investments | 1 | 1991-04-10 |
| Brytech, Inc. | 1 | 1986-09-03 |
| Oms | 1 | 1983-03-09 |
| Itt Corp. | 1 | 1976-12-16 |
Most recent HPG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K910601 | Nurion Industries | PATHFINDER | 1991-05-14 | 90 |
| K910124 | Triangle Investments | LOW VISION ENHANCEMENT SYSTEM (LVES) | 1991-04-10 | 89 |
| K903558 | Nurion Industries | LASER CANE | 1990-09-27 | 50 |
| K902187 | Nurion Industries | POLARON | 1990-08-08 | 86 |
| K862338 | Brytech, Inc. | SENSORY 6 | 1986-09-03 | 75 |
Recalls for HPG devices
openFDA lists no recalls for product code HPG.
Frequently asked questions
What is FDA product code HPG?
HPG is the FDA product code for aid, vision, electronic, battery-powered. It is a Class I device, regulated under 21 CFR 886.5900 and reviewed by the Ophthalmic panel.
What device class is HPG?
Class I, regulation 21 CFR 886.5900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HPG?
Across 7 cleared submissions the average was 73 days from receipt to decision (median 86).
Which companies have the most HPG clearances?
Nurion Industries (3); Triangle Investments (1); Brytech, Inc. (1); Oms (1); Itt Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HPG
- Run a recall and safety report across every HPG manufacturer
- Watch product code HPG 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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