FDA product code HPQ: Headlamp, Operating, Ac-Powered
HPQ is the FDA product code for headlamp, operating, ac-powered. It is a Class II device, regulated under 21 CFR 886.4335 and reviewed by the Ophthalmic panel. FDA has cleared 5 510(k) submissions under HPQ, from 4 different applicants. The average 510(k) review took 91 days (median 104).
Classification
| Field | Value |
|---|---|
| Device name | Headlamp, Operating, Ac-Powered |
| Device class | Class II |
| Regulation | 21 CFR 886.4335 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HPQ clearance
Top HPQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Keeler Instruments, Inc. | 2 | 1986-08-21 |
| Welch Allyn, Inc. | 1 | 1995-07-14 |
| Neitz Instruments Company, Ltd. | 1 | 1995-06-08 |
| Kelleher Corp. | 1 | 1982-11-10 |
Most recent HPQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952289 | Welch Allyn, Inc. | WELCH ALLYN FIBER OPTIC HEADLIGNT | 1995-07-14 | 59 |
| K951337 | Neitz Instruments Company, Ltd. | FIBER HEAD LIGHT FH-300 | 1995-06-08 | 76 |
| K861747 | Keeler Instruments, Inc. | KEELER FIBEROPTIC HEADLAMP | 1986-08-21 | 107 |
| K861746 | Keeler Instruments, Inc. | KEELER DUAL LIGHTSOURCE | 1986-08-21 | 107 |
| K822272 | Kelleher Corp. | HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS | 1982-11-10 | 104 |
Recalls for HPQ devices
openFDA lists no recalls for product code HPQ.
Frequently asked questions
What is FDA product code HPQ?
HPQ is the FDA product code for headlamp, operating, ac-powered. It is a Class II device, regulated under 21 CFR 886.4335 and reviewed by the Ophthalmic panel.
What device class is HPQ?
Class II, regulation 21 CFR 886.4335. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HPQ?
Across 5 cleared submissions the average was 91 days from receipt to decision (median 104).
Which companies have the most HPQ clearances?
Keeler Instruments, Inc. (2); Welch Allyn, Inc. (1); Neitz Instruments Company, Ltd. (1); Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HPQ
- Run a recall and safety report across every HPQ manufacturer
- Watch product code HPQ 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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