FDA product code HNH: Ring, Ophthalmic (Flieringa)
HNH is the FDA product code for ring, ophthalmic (flieringa). It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 7 510(k) submissions under HNH, from 3 different applicants. The average 510(k) review took 64 days (median 71).
Classification
| Field | Value |
|---|---|
| Device name | Ring, Ophthalmic (Flieringa) |
| Device class | Class I |
| Regulation | 21 CFR 886.4350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Top HNH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ocular Instruments, Inc. | 5 | 1991-08-07 |
| Ameritek, Inc. | 1 | 1986-10-20 |
| Miami Eye Technology, Inc. | 1 | 1984-01-10 |
Most recent HNH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K912269 | Ocular Instruments, Inc. | LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RING | 1991-08-07 | 77 |
| K912268 | Ocular Instruments, Inc. | LANDERS NOTCHED VITRECTOMY LENS RING | 1991-08-07 | 77 |
| K912151 | Ocular Instruments, Inc. | LANDERS THREE STRUT VITRECTOMY LENS RING | 1991-07-25 | 71 |
| K902496 | Ocular Instruments, Inc. | LANDERS VITRECTOMY LENS RING W/INFUSION | 1990-07-24 | 49 |
| K863775 | Ameritek, Inc. | RK VACUUM FIXATION RING SYSTEM | 1986-10-20 | 24 |
Recalls for HNH devices
openFDA lists no recalls for product code HNH.
Frequently asked questions
What is FDA product code HNH?
HNH is the FDA product code for ring, ophthalmic (flieringa). It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HNH?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HNH?
Across 7 cleared submissions the average was 64 days from receipt to decision (median 71).
Which companies have the most HNH clearances?
Ocular Instruments, Inc. (5); Ameritek, Inc. (1); Miami Eye Technology, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HNH
- Run a recall and safety report across every HNH manufacturer
- Watch product code HNH 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.