Data / Medical devices / United States / Kal-Med, LLC.
Kal-Med, LLC.: FDA-registered device maker in Kensington, CT, United States, 1 510(k) clearance
Kal-Med, LLC. is registered with the FDA (registration 3006024395) in Kensington, CT, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 24, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006024395
- Address
- 570 Percival Ave, Kensington, CT, United States, 06037
- Owner or operator
- KAL-MED LLC (9094679)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- November 21, 2010
- Registered through
- 2026
- Brand names listed
- Clip-On Biteguard, PYLANT MONITOR, Scanhead protection cover, Tubeguard
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cuff, Tracheal Tube, Inflatable | BSK | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Endoscopic Bite Block | MNK | 1 | 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 24, 2020 | K191858 | Pylant Monitor | BSK | Substantially Equivalent | Kal-Med, LLC | accessdata.fda.gov |
Compare with other makers
Updated February 24, 2020. 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.