Primus Steam Sterilizers
by Primus Sterilizer Company, LLC
510(k) K991575
Primus Steam Sterilizers is a Class II device made by Primus Sterilizer Company, LLC, cleared under FDA 510(k) K991575 on 3 Dec 1999, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991575 | Date3 Dec 1999 | StatusActive |
Official records
- FDA 510(k) database K991575
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FLE
- FDA applicant
- Primus Sterilizer Co., Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 880.6880
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K991575
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| PRIMUS Sterilizer PSS5-AA-M | PSS5-AA-M | 00850005738008 | — | On the market |
| PRIMUS Sterilizer PSS5-B-M | PSS5-B-M | 00850005738022 | — | On the market |
| PRIMUS Sterilizer PSS5-C-M | PSS5-C-M | 00850005738039 | — | On the market |
| PRIMUS Sterilizer PSS5-D-M | PSS5-D-M | 00850005738046 | — | On the market |
| PRIMUS Sterilizer PSS5-E-M | PSS5-E-M | 00850005738053 | — | On the market |
| PRIMUS Sterilizer PSS5-F-M | PSS5-F-M | 00850005738060 | — | On the market |
| PRIMUS Sterilizer PSS5-G-M | PSS5-G-M | 00850005738077 | — | On the market |
| PRIMUS Sterilizer PSS5-J-M | PSS5-J-M | 00850005738091 | — | On the market |
| PRIMUS Sterilizer PSS5-K-M | PSS5-K-M | 00850005738107 | — | On the market |
Similar devices
Other devices filed under FDA product code FLE (Sterilizer, Steam).
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- JOSLYN STEAM STERILIZER / STEAM MODERNIZATION KIT by Joslyn Valve Corp.
- Family of Steam sterilizers B17 B22 Series by CEFLA s.c.
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- 15966-01 1596601 by Steris Mexico, S. de R.L. de C.V.