Steris System 1 Processor and 20 Sterilant
FDA 510(k) K875280 · Steris C/O Medical Device Consultants, Inc.
510(k) numberK875280
Submission
- Device name
- Steris System 1 Processor and 20 Sterilant
- Applicant
- Steris C/O Medical Device Consultants, Inc.
North Attleboro, MA, US - Received
- December 24, 1987
- Decision date
- September 13, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MED – Sterilant, Medical Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6885
- Specialty
- General Hospital
Other 510(k)s with product code MED
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid…MED · Traditional | STERIS Corporation | 04/08/2026SE |
| K232914 | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid…MED · Special | STERIS Corporation | 10/03/2023SE |
| K230582 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900MED · Special | STERIS Corporation | 03/28/2023SE |
| K222615 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…MED · Special | STERIS Corporation | 09/28/2022SE |
| K211607 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…MED · Traditional | STERIS Corporation | 09/07/2021SE |
| K210737 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…MED · Special | STERIS Corporation | 05/12/2021SE |
| K192929 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…MED · Special | STERIS Corporation | 12/10/2019SE |
| K191343 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900MED · Special | STERIS Corporation | 09/05/2019SE |
| K190104 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical…MED · Special | Steris Corporations | 03/22/2019SE |
| K182827 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900MED · Traditional | STERIS Corporation | 01/31/2019SE |
Questions and answers
When was Steris System 1 Processor and 20 Sterilant cleared by the FDA?
Steris System 1 Processor and 20 Sterilant (K875280) received a 510(k) decision of Substantially Equivalent on September 13, 1988, 264 days after the submission was received.
What is the product code of K875280?
The FDA product code is MED – Sterilant, Medical Devices, a Class II (moderate risk) device regulated under 21 CFR 880.6885.