Primus PSS Series Sterilizers
FDA 510(k) K926185 · Primus Sterilizer Co., Inc.
510(k) numberK926185
Submission
- Device name
- Primus PSS Series Sterilizers
- Applicant
- Primus Sterilizer Co., Inc.
Omaha, NE, US - Received
- December 8, 1992
- Decision date
- May 9, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FLE – Sterilizer, Steam
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6880
- Specialty
- General Hospital
Other 510(k)s with product code FLE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261055 | AMSCO 700 Steam SterilizerFLE · Traditional | STERIS Corporation | 06/24/2026SE |
| K260254 | Enbio PROFLE · Traditional | Enbio Group AG | 02/26/2026SE |
| K252307 | Getinge GSS67N Series Steam SterilizerFLE · Traditional | Maquet GmbH (A Getinge Group Company) | 01/22/2026SE |
| K250168 | Life Ultra 25L Tabletop Mono Chamber Steam SterilizerFLE · Traditional | Lucas Lifecare | 12/30/2025SE |
| K250164 | Cassette Autoclave (ACA5)FLE · Traditional | Guangzhou Ajax Medical Equipment Co., Ltd. | 08/14/2025SE |
| K243994 | Steam Sterilizer (2545D)FLE · Traditional | Ningbo Ican Machines Co., Ltd. | 06/06/2025SE |
| K243801 | FRONT-LINE Field Sterilizer (FL135)FLE · Special | Fort Defiance Industries, LLC | 03/07/2025SE |
| K233026 | Midmark Smart M9® Sterilizer, Midmark Smart M11® SterilizerFLE · Traditional | Midmark Corporation | 04/04/2024SE |
| K233504 | Lexa MINI (RIS-303, RIS-305)FLE · Traditional | W&H Sterilization S.R.L. | 02/08/2024SE |
| K233132 | PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)FLE · Abbreviated | Primus Sterilizer Company, LLC | 12/19/2023SE |
More from Primus Sterilizer Company, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K233132 | PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)FLE · Abbreviated | 12/19/2023SE |
| K221474 | PRIMUS Healthcare Sterilizer (Model PSS11-HC)FLE · Abbreviated | 02/10/2023SE |
| K093333 | Primus Steam Sterilizer PSS8-AA (16X16X26 Multi Functional Sterilizer), Lab/Lo…FLE · Abbreviated | 04/02/2010SE |
| K082817 | Primus Steam Sterilizer, Models PSS5-G-1 and PSS5-MFLE · Traditional | 05/21/2009SE |
| K991575 | Primus Steam SterilizersFLE · Abbreviated | 12/03/1999SE |
Questions and answers
When was Primus PSS Series Sterilizers cleared by the FDA?
Primus PSS Series Sterilizers (K926185) received a 510(k) decision of Substantially Equivalent on May 9, 1994, 517 days after the submission was received.
What is the product code of K926185?
The FDA product code is FLE – Sterilizer, Steam, a Class II (moderate risk) device regulated under 21 CFR 880.6880.