Data / Medical devices / United States / Dorel Juvenile Group, Inc.
Dorel Juvenile Group, Inc.: FDA-registered device maker in Columbus, IN, United States, 1 510(k) clearance
Dorel Juvenile Group, Inc. is registered with the FDA (registration 1000137876) in Columbus, IN, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 6, 1996. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000137876
- Address
- 2525 State Street, Columbus, IN, United States, 47201
- Owner or operator
- Dorel Juvenile Group (9009334)
- Roles
- Specification developer
- First device listed
- May 19, 2005
- Registered through
- 2026
- Brand names listed
- SAFETY 1ST NASAL ASPIRATOR, Safety 1st
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Specification developer | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | Specification developer | accessdata.fda.gov |
| Syringe, Ent | KCP | 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 |
|---|---|---|---|---|---|---|
| December 6, 1996 | K963276 | THE SAFETY 1ST DIGITAL PACIFIER | FLL | Substantially Equivalent | Safety 1st, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Ent
- All makers of First Aid Kit With Drug
- All makers of Continuous Measurement Thermometer
Updated December 6, 1996. 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.