Data / Medical devices / United States / Kiltex Corp.
Kiltex Corp.: FDA-registered device maker in Akron, OH, United States, 1 510(k) clearance
Kiltex Corp. is registered with the FDA (registration 1527493) in Akron, OH, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 25, 1996. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1527493
- Address
- 2064 Killian Road, Akron, OH, United States, 44312
- Owner or operator
- KILTEX CORP. (1527493)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 12, 2007
- Registered through
- 2026
- Brand names listed
- Kiltex Probe Cover, Tono Pen Probe Covers
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tonometer, Manual | HKY | 2 | Contract manufacturer | 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 |
|---|---|---|---|---|---|---|
| July 25, 1996 | K961029 | KILTEX PROBE COVER | IYO | Substantially Equivalent | Kiltex Corp. | accessdata.fda.gov |
Compare with other makers
Updated July 25, 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.