Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HNL — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
35 daysmedian FDA review time
84 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K843491 | CONCEPT FIBER OPTIC CANALICULUS INTUBA | Concept, Inc. | 1984-10-05 | 29 | 0 |
| K840861 | TSE-ANDERSON MODIFIED LACRIMAL GROOV | Hansen Ophthalmic Development Lab | 1984-05-09 | 75 | 0 |
| K833671 | STERILE OIL AND GUIDEWIRE | CooperVision, Inc. | 1984-01-10 | 84 | 0 |
| K831901 | LACIMAL INTUBATION SETS | Visitec Co. | 1983-07-12 | 28 | 0 |
| K813187 | PILLING LACRIMAL INTUBATION SYSTEM | Narco Scientific | 1982-01-28 | 73 | 0 |
| K812255 | ETHICON LACRIMAL STENT | ETHICON, Inc. | 1981-08-20 | 8 | 0 |
| K802845 | CONCEPT CANALICULUS INTUBATION SET | Concept, Inc. | 1980-12-17 | 35 | 0 |
| K801232 | JACKSON LACRIMAL INTUBATION SET | Storz Instrument Co. | 1980-06-17 | 21 | 0 |
| K800089 | CRAWFORD LACRIMAL INTUBATION SET | Jedmed Instrument Co. | 1980-03-03 | 49 | 0 |
| K770194 | NASO-LACRIMAL DUCT INSERT | Concept, Inc. | 1977-02-14 | 14 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda