FDA product code HPM: Locator, Metal, Electronic
HPM is the FDA product code for locator, metal, electronic. It is a Class II device, regulated under 21 CFR 886.4400 and reviewed by the Ophthalmic panel. FDA has cleared 4 510(k) submissions under HPM, from 4 different applicants. The average 510(k) review took 114 days (median 84).
Classification
| Field | Value |
|---|---|
| Device name | Locator, Metal, Electronic |
| Device class | Class II |
| Regulation | 21 CFR 886.4400 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HPM clearance
Top HPM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Adams Electronics, Inc. | 1 | 2000-12-22 |
| Fatswith Intl., Inc. | 1 | 1996-04-01 |
| Pmt Corp. | 1 | 1991-08-12 |
| Keeler Optical Products , Ltd. | 1 | 1978-12-04 |
Most recent HPM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K003305 | Adams Electronics, Inc. | PEDIATRIC INGESTASCAN | 2000-12-22 | 63 |
| K953277 | Fatswith Intl., Inc. | SHADOW MEDAL LOCATOR | 1996-04-01 | 263 |
| K911886 | Pmt Corp. | PMT METAL LOCATOR, MODEL 3630-1 | 1991-08-12 | 105 |
| K781892 | Keeler Optical Products , Ltd. | LOCATOR, FOREIGN BODY | 1978-12-04 | 26 |
Recalls for HPM devices
openFDA lists no recalls for product code HPM.
Frequently asked questions
What is FDA product code HPM?
HPM is the FDA product code for locator, metal, electronic. It is a Class II device, regulated under 21 CFR 886.4400 and reviewed by the Ophthalmic panel.
What device class is HPM?
Class II, regulation 21 CFR 886.4400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HPM?
Across 4 cleared submissions the average was 114 days from receipt to decision (median 84).
Which companies have the most HPM clearances?
Adams Electronics, Inc. (1); Fatswith Intl., Inc. (1); Pmt Corp. (1); Keeler Optical Products , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HPM
- Run a recall and safety report across every HPM manufacturer
- Watch product code HPM 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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