FDA product code HNL: Probe, Lachrymal
HNL is the FDA product code for probe, lachrymal. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 10 510(k) submissions under HNL, from 8 different applicants. The average 510(k) review took 42 days (median 32). FDA has posted 1 recall for HNL devices.
Classification
| Field | Value |
|---|---|
| Device name | Probe, 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 HNL clearance
Top HNL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Concept, Inc. | 3 | 1984-10-05 |
| Hansen Ophthalmic Development Lab | 1 | 1984-05-09 |
| CooperVision, Inc. | 1 | 1984-01-10 |
| Visitec Co. | 1 | 1983-07-12 |
| Narco Scientific | 1 | 1982-01-28 |
3 more applicants have HNL clearances. See the full list in Caduvo.
Most recent HNL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K843491 | Concept, Inc. | CONCEPT FIBER OPTIC CANALICULUS INTUBA | 1984-10-05 | 29 |
| K840861 | Hansen Ophthalmic Development Lab | TSE-ANDERSON MODIFIED LACRIMAL GROOV | 1984-05-09 | 75 |
| K833671 | CooperVision, Inc. | STERILE OIL AND GUIDEWIRE | 1984-01-10 | 84 |
| K831901 | Visitec Co. | LACIMAL INTUBATION SETS | 1983-07-12 | 28 |
| K813187 | Narco Scientific | PILLING LACRIMAL INTUBATION SYSTEM | 1982-01-28 | 73 |
Recalls for HNL devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-02-26.
Frequently asked questions
What is FDA product code HNL?
HNL is the FDA product code for probe, lachrymal. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HNL?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HNL?
Across 10 cleared submissions the average was 42 days from receipt to decision (median 32).
Which companies have the most HNL clearances?
Concept, Inc. (3); Hansen Ophthalmic Development Lab (1); CooperVision, Inc. (1); Visitec Co. (1); Narco Scientific (1).
Have HNL devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-02-26.
Next steps
- Run an FDA pathway report with predicate devices for product code HNL
- Run a recall and safety report across every HNL manufacturer
- Watch product code HNL 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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