FDA product code HNC: Specula, Ophthalmic
HNC is the FDA product code for specula, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 11 510(k) submissions under HNC, from 9 different applicants. The average 510(k) review took 43 days (median 18). FDA has posted 1 recall for HNC devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Specula, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.4350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HNC clearance
Top HNC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| V. Mueller O.V. Baxter Healthcare Corp. | 3 | 1976-11-02 |
| Stephens Instruments | 1 | 2002-11-01 |
| Laser Center Dev. Corp. | 1 | 1998-07-15 |
| Eyefix, Inc. | 1 | 1996-12-17 |
| Keeler Instruments, Inc. | 1 | 1986-10-31 |
4 more applicants have HNC clearances. See the full list in Caduvo.
Most recent HNC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022836 | Stephens Instruments | STEPHENS DISPOSABLE SPECULUM | 2002-11-01 | 66 |
| K981235 | Laser Center Dev. Corp. | OCULOSTAT | 1998-07-15 | 103 |
| K964289 | Eyefix, Inc. | EYE FIXATION SPECULUM | 1996-12-17 | 50 |
| K863989 | Keeler Instruments, Inc. | THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER) | 1986-10-31 | 17 |
| K863664 | Myocure, Inc. | OPHTHALMIC SURGICAL SPECULUM | 1986-09-25 | 7 |
Recalls for HNC devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code HNC?
HNC is the FDA product code for specula, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HNC?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HNC?
Across 11 cleared submissions the average was 43 days from receipt to decision (median 18).
Which companies have the most HNC clearances?
V. Mueller O.V. Baxter Healthcare Corp. (3); Stephens Instruments (1); Laser Center Dev. Corp. (1); Eyefix, Inc. (1); Keeler Instruments, Inc. (1).
Have HNC devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code HNC
- Run a recall and safety report across every HNC manufacturer
- Watch product code HNC 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.
All Ophthalmic product codes · FDA product code lookup · 510(k) database search · 510(k) review times