Woodlyn, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Woodlyn, Inc.” (first 1984, latest 1993), across 13 product codes in 2 review panels. Median 510(k) review time under this name: 74 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HLI | Ophthalmoscope, Ac-Powered | 5 | 5 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 2 | 2 |
| HPC | Set, Lens, Trial, Ophthalmic | 2 | 2 |
| FSO | Microscope, Surgical, General & Plastic Surgery | 1 | 1 |
| HKN | Refractor, Manual, Non-Powered, Including Phoropter | 1 | 1 |
| HKX | Tonometer, Ac-Powered | 1 | 1 |
| HLM | Instrument, Measuring, Lens, Ac-Powered | 1 | 1 |
| HLQ | Keratoscope, Ac-Powered | 1 | 1 |
| HME | Chair, Ophthalmic, Ac-Powered | 1 | 1 |
| HMG | Stand, Instrument, Ophthalmic, Non-Powered | 1 | 1 |
Plus 3 more product codes.
Review panels
Most recent Woodlyn, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931303 | WOODLYN OPERATION MICROSCOPE | FSO | 1993-06-25 | 102 |
| K920861 | WOODLYN CLASSIC LENSMETER | HLM | 1992-07-30 | 156 |
| K900478 | WOODLYN FULL APERTURE TRIAL LENS SET | HPC | 1990-02-21 | 20 |
| K900477 | WOODLYN CLASSIC SLIT LAMP MODEL SMM | HJO | 1990-02-21 | 20 |
| K900476 | WOODLYN SLIT LAMP MODEL HR-1 | HJO | 1990-02-21 | 20 |
| K890992 | WOODLYN OPHTHALMIC PROJECTOR | HOS | 1989-05-17 | 79 |
| K874900 | WOODLYN CLASSIC REFRACTOR, PHOROPTOR | HKN | 1987-12-23 | 22 |
| K843812 | WOODLYN CLASSIC CATARACT ACUITY TEST | HLI | 1984-12-11 | 74 |
| K841767 | WOODLYN CLASSIC KERATOMETER | HLI | 1984-08-07 | 102 |
| K841765 | WOODLYN STANDARD SLIT LAMP HSSL-ST | HLQ | 1984-08-07 | 102 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Woodlyn, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Woodlyn, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Woodlyn, Inc.” (first 1984, latest 1993), across 13 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Woodlyn, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Woodlyn, Inc. is 74 days.
Which FDA product codes appear under Woodlyn, Inc.?
The most frequent FDA product codes under this applicant name are HLI (Ophthalmoscope, Ac-Powered, 5); HJO (Biomicroscope, Slit-Lamp, Ac-Powered, 2); HPC (Set, Lens, Trial, Ophthalmic, 2).
Next steps
- See all 19 Woodlyn, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HLI, Woodlyn, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.