FDA product code HQM: Keratoprosthesis, Permanent Implant
HQM is the FDA product code for keratoprosthesis, permanent implant. It is a Class II device, regulated under 21 CFR 886.3400 and reviewed by the Ophthalmic panel. FDA has cleared 4 510(k) submissions under HQM, from 4 different applicants. The average 510(k) review took 210 days (median 191).
Classification
| Field | Value |
|---|---|
| Device name | Keratoprosthesis, Permanent Implant |
| Device class | Class II |
| Regulation | 21 CFR 886.3400 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for HQM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 93 |
Compare with all 510(k) review times · Search every HQM clearance
Top HQM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Massachusetts Eye and Ear Infirmary D/B/A Boston | 1 | 2019-01-30 |
| Massachusetts Eye & Ear Infirmary | 1 | 2013-05-10 |
| Argus Biomedical Pty, Ltd. | 1 | 2002-08-29 |
| Mackeen Consultants, Ltd. | 1 | 1992-01-21 |
Most recent HQM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K182986 | Massachusetts Eye and Ear Infirmary D/B/A Boston | Boston Keratoprosthesis, Type I Lucia | 2019-01-30 | 93 |
| K121203 | Massachusetts Eye & Ear Infirmary | BOSTON KERATOPROSTHESIS OR BOSTON KPRO | 2013-05-10 | 385 |
| K013756 | Argus Biomedical Pty, Ltd. | ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) | 2002-08-29 | 289 |
| K915062 | Mackeen Consultants, Ltd. | DOHLMAN DOANE KERATOPROTHESIS | 1992-01-21 | 74 |
Recalls for HQM devices
openFDA lists no recalls for product code HQM.
Frequently asked questions
What is FDA product code HQM?
HQM is the FDA product code for keratoprosthesis, permanent implant. It is a Class II device, regulated under 21 CFR 886.3400 and reviewed by the Ophthalmic panel.
What device class is HQM?
Class II, regulation 21 CFR 886.3400. Typical premarket route: 510(k).
How long does a 510(k) take for product code HQM?
Across 4 cleared submissions the average was 210 days from receipt to decision (median 191).
Which companies have the most HQM clearances?
Massachusetts Eye and Ear Infirmary D/B/A Boston (1); Massachusetts Eye & Ear Infirmary (1); Argus Biomedical Pty, Ltd. (1); Mackeen Consultants, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HQM
- Run a recall and safety report across every HQM manufacturer
- Watch product code HQM 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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