Data / Medical devices / United States / Primus Sterilizer Company, LLC.
Primus Sterilizer Company, LLC.: FDA-registered device maker in Great Bend, KS, United States, 5 510(k) clearances
Primus Sterilizer Company, LLC. is registered with the FDA (registration 1932355) in Great Bend, KS, United States. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated December 19, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1932355
- FEI number
- 1000119270
- Address
- 175 N Us Hwy 281, Great Bend, KS, United States, 67530
- Owner or operator
- PRIMUS Sterilizer Company, LLC (9005293)
- Roles
- Manufacturer
- First device listed
- October 10, 2007
- Registered through
- 2026
- Brand names listed
- Primus Sterilizer PSS11-HA, Primus Sterilizer PSS11-HB, Sterilizer,steam, one, three, two
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sterilizer, Steam | FLE | 2 | 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 |
|---|---|---|---|---|---|---|
| December 19, 2023 | K233132 | PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) | FLE | Substantially Equivalent | Primus Sterilizer Company, LLC | accessdata.fda.gov |
| February 10, 2023 | K221474 | PRIMUS Healthcare Sterilizer (Model PSS11-HC) | FLE | Substantially Equivalent | Primus Sterilizer Company, LLC | accessdata.fda.gov |
| April 2, 2010 | K093333 | PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8 | FLE | Substantially Equivalent | Primus Sterilizer Company, LLC | accessdata.fda.gov |
| May 21, 2009 | K082817 | PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M | FLE | Substantially Equivalent | Primus Sterilizer Company, LLC | accessdata.fda.gov |
| December 3, 1999 | K991575 | PRIMUS STEAM STERILIZERS | FLE | Substantially Equivalent | Primus Sterilizer Co., Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 19, 2023. 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.