Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Woodlyn, Inc. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
102 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931303 | WOODLYN OPERATION MICROSCOPE | Woodlyn, Inc. | 1993-06-25 | 102 | 0 |
| K920861 | WOODLYN CLASSIC LENSMETER | Woodlyn, Inc. | 1992-07-30 | 156 | 0 |
| K900476 | WOODLYN SLIT LAMP MODEL HR-1 | Woodlyn, Inc. | 1990-02-21 | 20 | 0 |
| K900477 | WOODLYN CLASSIC SLIT LAMP MODEL SMM | Woodlyn, Inc. | 1990-02-21 | 20 | 0 |
| K900478 | WOODLYN FULL APERTURE TRIAL LENS SET | Woodlyn, Inc. | 1990-02-21 | 20 | 0 |
| K890992 | WOODLYN OPHTHALMIC PROJECTOR | Woodlyn, Inc. | 1989-05-17 | 79 | 0 |
| K874900 | WOODLYN CLASSIC REFRACTOR, PHOROPTOR | Woodlyn, Inc. | 1987-12-23 | 22 | 0 |
| K843812 | WOODLYN CLASSIC CATARACT ACUITY TEST | Woodlyn, Inc. | 1984-12-11 | 74 | 0 |
| K841767 | WOODLYN CLASSIC KERATOMETER | Woodlyn, Inc. | 1984-08-07 | 102 | 0 |
| K841764 | WOODLYN CLASSIC JAVAL OPHTHALMOMETER | Woodlyn, Inc. | 1984-08-07 | 102 | 0 |
| K841761 | WOODLYN CLASSIC SLIT LAMP HSSL-CL | Woodlyn, Inc. | 1984-08-07 | 102 | 0 |
| K841765 | WOODLYN STANDARD SLIT LAMP HSSL-ST | Woodlyn, Inc. | 1984-08-07 | 102 | 0 |
| K841763 | WOODLYN SLIT LAMP HSSL-EC | Woodlyn, Inc. | 1984-08-02 | 97 | 0 |
| K841762 | WOODLYN APPLANATION TONOMETER | Woodlyn, Inc. | 1984-08-02 | 97 | 0 |
| K842045 | WOODLYN CLASSIC EXAM. CHAIR | Woodlyn, Inc. | 1984-06-19 | 29 | 0 |
| K841760 | WOODLYN CLASSIC INSTRUMENT STAND | Woodlyn, Inc. | 1984-06-19 | 53 | 0 |
| K841766 | WOODLYN CLASSIC TRIAL LENS SET | Woodlyn, Inc. | 1984-06-01 | 35 | 0 |
| K841759 | OPHTHALMIC TABLE | Woodlyn, Inc. | 1984-06-01 | 35 | 0 |
| K841768 | WOODLYN LIGHTWEIGHT TRIAL FRAME | Woodlyn, Inc. | 1984-06-01 | 35 | 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