Data / Medical devices / United States / Oak Ridge Products
Oak Ridge Products: FDA-registered device maker in McHenry, IL, United States, 3 510(k) clearances
Oak Ridge Products is registered with the FDA (registration 1419823) in McHenry, IL, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 9, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1419823
- Address
- 4612 Century Ct, McHenry, IL, United States, 60050
- Owner or operator
- OAK RIDGE PRODUCTS, LLC (1419823)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 3, 1984
- Registered through
- 2026
- Brand names listed
- 0102-0100 Graduated Med Cup, 0103-0100 Economy Med Cup, Assure SD Sharps Containers, Container, Specimen, Non-Sterile, Container, sharps, DealMed, MC-79 MED CUP, Multi-purpose Sharps Container and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Liquid Medication, Graduated | KYW | 1 | Specification developer | accessdata.fda.gov |
| Container, Sharps | MMK | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Specification developer | accessdata.fda.gov |
| Razor, Surgical | LWK | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 9, 2016 | K161180 | Oak Ridge Products Sharps Containers | MMK | Substantially Equivalent | Oak Ridge Products, LLC | accessdata.fda.gov |
| October 24, 2014 | K141759 | OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS | MMK | Substantially Equivalent | Oak Ridge Products, LLC | accessdata.fda.gov |
| June 21, 2013 | K130281 | OAK RIDGE PRODUCTS SHARP CONTAINER | MMK | Substantially Equivalent | Oak Ridge Products, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Container, Sharps
- All makers of Razor, Surgical
- All makers of Container, Liquid Medication, Graduated
- All makers of Container, Specimen, Non-Sterile
Updated June 9, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.