FDA product code HNW: Dilator, Lachrymal
HNW is the FDA product code for dilator, lachrymal. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 3 510(k) submissions under HNW, from 3 different applicants. The average 510(k) review took 35 days (median 25).
Classification
| Field | Value |
|---|---|
| Device name | Dilator, Lachrymal |
| 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 HNW clearance
Top HNW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intermedics Intraocular, Inc. | 1 | 1986-06-17 |
| Premier Dental Products Co. | 1 | 1984-05-09 |
| Koi, Inc. | 1 | 1981-08-18 |
Most recent HNW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K862070 | Intermedics Intraocular, Inc. | INTER-SHARP | 1986-06-17 | 18 |
| K841002 | Premier Dental Products Co. | LACHRYMAL PROBES-VARIOUS | 1984-05-09 | 61 |
| K812097 | Koi, Inc. | KOI LACREMAL HOOK & DILATOR | 1981-08-18 | 25 |
Recalls for HNW devices
openFDA lists no recalls for product code HNW.
Frequently asked questions
What is FDA product code HNW?
HNW is the FDA product code for dilator, lachrymal. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HNW?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HNW?
Across 3 cleared submissions the average was 35 days from receipt to decision (median 25).
Which companies have the most HNW clearances?
Intermedics Intraocular, Inc. (1); Premier Dental Products Co. (1); Koi, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HNW
- Run a recall and safety report across every HNW manufacturer
- Watch product code HNW 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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