Data / Medical devices / United States / Pristech Products, Inc.
Pristech Products, Inc.: FDA-registered device maker in San Antonio, TX, United States, 1 510(k) clearance
Pristech Products, Inc. is registered with the FDA (registration 1450530) in San Antonio, TX, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 3, 1994. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1450530
- Address
- 6952 Fairgrounds Pkwy # 107, San Antonio, TX, United States, 78238
- Owner or operator
- Pristech Products, Inc. (10042028)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- October 9, 2012
- Registered through
- 2026
- Brand names listed
- WarmGel® Infant Heel Warmers
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Infant Heel Warmer (Chemical Heat Pack) | MPO | 1 | Contract manufacturer | accessdata.fda.gov |
| Laparoscopic Accessories, Gynecologic | NWV | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| February 3, 1994 | K934631 | TRANSWARMER | IMD | Substantially Equivalent | Prism Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscopic Accessories, Gynecologic
- All makers of Pack, Hot Or Cold, Disposable
- All makers of Infant Heel Warmer (Chemical Heat Pack)
Updated February 3, 1994. 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.