Data / Medical devices / United States / TPC Inc.
TPC Inc.: FDA-registered device maker in New York, NY, United States, 2 510(k) clearances
TPC Inc. is registered with the FDA (registration 3005836389) in New York, NY, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 13, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005836389
- Address
- 447 Broadway Fl 2 Pmb 376, New York, NY, United States, 10013
- Owner or operator
- TPC Inc. (10085755)
- Roles
- Specification developer
- First device listed
- April 23, 2026
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Tampon, Menstrual, Unscented | HEB | 2 | 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 |
|---|---|---|---|---|---|---|
| August 13, 2025 | K251033 | Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons | HEB | Substantially Equivalent | Unibeauty (Hubei) Technology Co., Ltd. | accessdata.fda.gov |
| March 3, 2017 | K162746 | Ontex and other proprietary names | HEB | Substantially Equivalent | Ontex Bvba | accessdata.fda.gov |
Compare with other makers
Updated August 13, 2025. 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.