FDA product code HQX: Implant, Orbital, Extra-Ocular
HQX is the FDA product code for implant, orbital, extra-ocular. It is a Class II device, regulated under 21 CFR 886.3340 and reviewed by the Ophthalmic panel. FDA has cleared 16 510(k) submissions under HQX, from 11 different applicants. The average 510(k) review took 101 days (median 77). FDA has posted 13 recalls for HQX devices.
Classification
| Field | Value |
|---|---|
| Device name | Implant, Orbital, Extra-Ocular |
| Device class | Class II |
| Regulation | 21 CFR 886.3340 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every HQX clearance
Top HQX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Oculo Plastik, Inc. | 5 | 1990-05-22 |
| Fci Ophthalmics, Inc. | 2 | 1998-09-18 |
| Microvision, Inc. | 1 | 2003-01-08 |
| Bio-Vascular, Inc. | 1 | 1998-11-06 |
| Mira, Inc. | 1 | 1996-06-05 |
6 more applicants have HQX clearances. See the full list in Caduvo.
Most recent HQX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023481 | Microvision, Inc. | MICROVISION SCLERAL BUCKLING COMPONENTS | 2003-01-08 | 83 |
| K983581 | Bio-Vascular, Inc. | OCU-GUARD AND OCU-GUARD SUPPLE | 1998-11-06 | 24 |
| K980816 | Fci Ophthalmics, Inc. | RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES | 1998-09-18 | 199 |
| K963219 | Fci Ophthalmics, Inc. | RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES | 1996-10-28 | 73 |
| K950806 | Mira, Inc. | SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS | 1996-06-05 | 469 |
Recalls for HQX devices
13 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2002-11-29.
Frequently asked questions
What is FDA product code HQX?
HQX is the FDA product code for implant, orbital, extra-ocular. It is a Class II device, regulated under 21 CFR 886.3340 and reviewed by the Ophthalmic panel.
What device class is HQX?
Class II, regulation 21 CFR 886.3340. Typical premarket route: 510(k).
How long does a 510(k) take for product code HQX?
Across 16 cleared submissions the average was 101 days from receipt to decision (median 77).
Which companies have the most HQX clearances?
Oculo Plastik, Inc. (5); Fci Ophthalmics, Inc. (2); Microvision, Inc. (1); Bio-Vascular, Inc. (1); Mira, Inc. (1).
Have HQX devices been recalled?
Yes: 13 product recalls across 1 recall events; the most recent began 2002-11-29.
Next steps
- Run an FDA pathway report with predicate devices for product code HQX
- Run a recall and safety report across every HQX manufacturer
- Watch product code HQX 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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