FDA product code HQN: Conformer, Ophthalmic
HQN is the FDA product code for conformer, ophthalmic. It is a Class II device, regulated under 21 CFR 886.3130 and reviewed by the Ophthalmic panel. FDA has cleared 7 510(k) submissions under HQN, from 6 different applicants. The average 510(k) review took 125 days (median 126). FDA has posted 1 recall for HQN devices.
Classification
| Field | Value |
|---|---|
| Device name | Conformer, Ophthalmic |
| Device class | Class II |
| Regulation | 21 CFR 886.3130 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HQN clearance
Top HQN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Storz Instrument Co. | 2 | 1992-07-17 |
| Porex Surgical, Inc. | 1 | 1998-01-20 |
| Southwest Artificial Eyes, Inc. | 1 | 1997-07-07 |
| Xavier A. Guerra, Ocularist, Inc. | 1 | 1997-07-07 |
| Kolberg Ocular Products, Inc. | 1 | 1995-01-13 |
1 more applicants have HQN clearances. See the full list in Caduvo.
Most recent HQN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972034 | Porex Surgical, Inc. | MEDPOR OCULAR CONFORMER | 1998-01-20 | 232 |
| K970318 | Southwest Artificial Eyes, Inc. | OCULAR CONFORMER | 1997-07-07 | 160 |
| K970319 | Xavier A. Guerra, Ocularist, Inc. | OCULAR CONFORMER | 1997-07-07 | 160 |
| K945110 | Kolberg Ocular Products, Inc. | KOLBERG OPHTHALMIC CONFORMER | 1995-01-13 | 87 |
| K921221 | Storz Instrument Co. | STERILE/SINGLE USE SYMBLEPHARON RING | 1992-07-17 | 126 |
Recalls for HQN devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-03-28.
Frequently asked questions
What is FDA product code HQN?
HQN is the FDA product code for conformer, ophthalmic. It is a Class II device, regulated under 21 CFR 886.3130 and reviewed by the Ophthalmic panel.
What device class is HQN?
Class II, regulation 21 CFR 886.3130. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HQN?
Across 7 cleared submissions the average was 125 days from receipt to decision (median 126).
Which companies have the most HQN clearances?
Storz Instrument Co. (2); Porex Surgical, Inc. (1); Southwest Artificial Eyes, Inc. (1); Xavier A. Guerra, Ocularist, Inc. (1); Kolberg Ocular Products, Inc. (1).
Have HQN devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-03-28.
Next steps
- Run an FDA pathway report with predicate devices for product code HQN
- Run a recall and safety report across every HQN manufacturer
- Watch product code HQN 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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