Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lacrimedics, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
93 daysmedian FDA review time
210 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161673 | LacriPro Punctum Plug | Lacrimedics, Inc. | 2016-11-18 | 155 | 0 |
| K140026 | COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST | Lacrimedics, Inc. | 2014-06-03 | 148 | 1 |
| K030300 | OPAQUE HERRICK LACRIMAL PLUG | Lacrimedics, Inc. | 2003-05-09 | 100 | 0 |
| K021831 | OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3 | Lacrimedics, Inc. | 2002-07-01 | 27 | 0 |
| K001737 | OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM | Lacrimedics, Inc. | 2000-06-19 | 12 | 0 |
| K963708 | HERRICK ULTIMATE PUNCTUM PLUG | Lacrimedics, Inc. | 1997-04-14 | 210 | 0 |
| K963501 | HERRICK ULTIMATE PUNCTUM PLUG | Lacrimedics, Inc. | 1997-04-14 | 223 | 0 |
| K944402 | FOCOMETER | Lacrimedics, Inc. | 1994-11-22 | 71 | 0 |
| K896175 | HERRICK LACRIMAL PLUG TM. | Lacrimedics, Inc. | 1990-01-22 | 89 | 0 |
| K895342 | COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST | Lacrimedics, Inc. | 1989-11-02 | 63 | 0 |
| K890714 | LACRIMAL EFFICIENCY TEST (TM) | Lacrimedics, Inc. | 1989-05-17 | 93 | 0 |
| K850649 | ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT | Lacrimedics, Inc. | 1985-05-21 | 91 | 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