FDA product code HNN: Knife, Ophthalmic
HNN is the FDA product code for knife, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 54 510(k) submissions under HNN, from 30 different applicants. The average 510(k) review took 54 days (median 32). FDA has posted 155 recalls for HNN devices, 43 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Knife, 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 HNN clearance
Top HNN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Myocure, Inc. | 5 | 1987-12-23 |
| Keeler Instruments, Inc. | 4 | 1986-12-15 |
| Storz Instrument Co. | 3 | 1986-05-28 |
| Med-Tech Develoment Corp. | 3 | 1986-03-28 |
| Rudolph Beaver, Inc. | 3 | 1986-02-12 |
25 more applicants have HNN clearances. See the full list in Caduvo.
Most recent HNN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K110166 | Alcon Research, Ltd. | CLEARCUT S SAFETY KNIFE | 2011-05-20 | 120 |
| K922378 | Microptics Development Laboratory | OPHTHALMIC KNIFE | 1992-12-10 | 204 |
| K882402 | Optical Center | RETRACTIVE INCISION MICROMETER (RIM) GUAGE | 1988-08-22 | 73 |
| K881669 | Advanced Surgical Products, Inc. | MVR/STILETTO BLADE 20GA. - P/N 1900 | 1988-05-13 | 25 |
| K874979 | Advanced Surgical Products, Inc. | PRISMA DISPOSABLE MVR/STILETTO BLADE | 1988-04-13 | 133 |
Recalls for HNN devices
155 product recalls in 27 recall events; 43 initiated in the last five years and 42 still open. Most recent: 2026-04-23.
| Year | Recalls |
|---|---|
| 2017 | 44 |
| 2018 | 1 |
| 2019 | 2 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 29 |
| 2025 | 8 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code HNN?
HNN is the FDA product code for knife, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HNN?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HNN?
Across 54 cleared submissions the average was 54 days from receipt to decision (median 32).
Which companies have the most HNN clearances?
Myocure, Inc. (5); Keeler Instruments, Inc. (4); Storz Instrument Co. (3); Med-Tech Develoment Corp. (3); Rudolph Beaver, Inc. (3).
Have HNN devices been recalled?
Yes: 155 product recalls across 27 recall events; the most recent began 2026-04-23.
Next steps
- Run an FDA pathway report with predicate devices for product code HNN
- Run a recall and safety report across every HNN manufacturer
- Watch product code HNN 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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