FDA product code HNR: Forceps, Ophthalmic
HNR is the FDA product code for forceps, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 44 510(k) submissions under HNR, from 26 different applicants. The average 510(k) review took 40 days (median 29). FDA has posted 16 recalls for HNR devices, 14 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Forceps, 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 HNR clearance
Top HNR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edward Weck, Inc. | 14 | 1980-07-28 |
| Alcon Laboratories | 2 | 1989-12-04 |
| Western Medical Products, Inc. | 2 | 1989-08-15 |
| Keeler Instruments, Inc. | 2 | 1986-10-31 |
| Storz Instrument Co. | 2 | 1986-04-15 |
21 more applicants have HNR clearances. See the full list in Caduvo.
Most recent HNR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022835 | Stephens Instruments | STEPHENS DISPOSABLE FORCEPS | 2002-11-01 | 66 |
| K895434 | Alcon Laboratories | ALCON FOLDING FORCEPS | 1989-12-04 | 87 |
| K891487 | Western Medical Products, Inc. | SOFT LENS FOLDING BLOCK | 1989-08-15 | 151 |
| K893199 | Allergan Medical Optics | PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR | 1989-06-16 | 51 |
| K885230 | Alcon Laboratories | MCDONALD FOLDING FORCEPS | 1989-05-17 | 148 |
Recalls for HNR devices
16 product recalls in 5 recall events; 14 initiated in the last five years and 13 still open. Most recent: 2026-03-25.
| Year | Recalls |
|---|---|
| 2023 | 1 |
| 2025 | 1 |
| 2026 | 12 |
Frequently asked questions
What is FDA product code HNR?
HNR is the FDA product code for forceps, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HNR?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HNR?
Across 44 cleared submissions the average was 40 days from receipt to decision (median 29).
Which companies have the most HNR clearances?
Edward Weck, Inc. (14); Alcon Laboratories (2); Western Medical Products, Inc. (2); Keeler Instruments, Inc. (2); Storz Instrument Co. (2).
Have HNR devices been recalled?
Yes: 16 product recalls across 5 recall events; the most recent began 2026-03-25.
Next steps
- Run an FDA pathway report with predicate devices for product code HNR
- Run a recall and safety report across every HNR manufacturer
- Watch product code HNR 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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