FDA product code HPZ: Implant, Eye Sphere
HPZ is the FDA product code for implant, eye sphere. It is a Class II device, regulated under 21 CFR 886.3320 and reviewed by the Ophthalmic panel. FDA has cleared 39 510(k) submissions under HPZ, 1 in the last five years, from 24 different applicants. The average 510(k) review took 126 days (median 98). FDA has posted 4 recalls for HPZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Implant, Eye Sphere |
| Device class | Class II |
| Regulation | 21 CFR 886.3320 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for HPZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 298 |
Compare with all 510(k) review times · Search every HPZ clearance
Top HPZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Oculo Plastik, Inc. | 7 | 2011-09-15 |
| Porex Surgical, Inc. | 6 | 2007-08-08 |
| Integrated Orbital Implants, Inc. | 3 | 2001-02-07 |
| Fci Ophthalmics, Inc. | 2 | 2003-08-22 |
| Miguel Martinez M.D. | 2 | 1995-02-14 |
19 more applicants have HPZ clearances. See the full list in Caduvo.
Most recent HPZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K212741 | Fci (France Chirurgie Instrumentation) Sas | EZYPOR | 2022-06-24 | 298 |
| K123764 | Oculo-Plastik, Inc. | DURETTE OCULAR IMPLANT | 2013-01-31 | 55 |
| K110554 | Ceramisys, Ltd. | BIOCERAMIC ORBITAL IMPLANT, ORBTEX | 2011-11-02 | 247 |
| K112176 | Oculo Plastik, Inc. | SILICONE SPHERES | 2011-09-15 | 49 |
| K083342 | Evera Medical, Inc. | ORBITAL RECONSTRUCTIVE IMPLANT II | 2009-03-12 | 120 |
Recalls for HPZ devices
4 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-03-20.
Frequently asked questions
What is FDA product code HPZ?
HPZ is the FDA product code for implant, eye sphere. It is a Class II device, regulated under 21 CFR 886.3320 and reviewed by the Ophthalmic panel.
What device class is HPZ?
Class II, regulation 21 CFR 886.3320. Typical premarket route: 510(k).
How long does a 510(k) take for product code HPZ?
Across 39 cleared submissions the average was 126 days from receipt to decision (median 98).
Which companies have the most HPZ clearances?
Oculo Plastik, Inc. (7); Porex Surgical, Inc. (6); Integrated Orbital Implants, Inc. (3); Fci Ophthalmics, Inc. (2); Miguel Martinez M.D. (2).
Have HPZ devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2012-03-20.
Next steps
- Run an FDA pathway report with predicate devices for product code HPZ
- Run a recall and safety report across every HPZ manufacturer
- Watch product code HPZ 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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