Sterrad 50 & Sterrad 100S Sterilizers
FDA 510(k) K023290 · Advanced Sterilization Products
510(k) numberK023290
Submission
- Device name
- Sterrad 50 & Sterrad 100S Sterilizers
- Applicant
- Advanced Sterilization Products
Irvin, CA, US - Received
- October 2, 2002
- Decision date
- April 3, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FLF – Sterilizer, Ethylene-Oxide Gas
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6860
- Specialty
- General Hospital
Other 510(k)s with product code FLF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192978 | EOGas 4 Ethylene Oxide Gas SterilizerFLF · Traditional | Andersen Sterilizers, Inc. | 11/12/2020SE |
| K170432 | Anprolene AN75 Ethylene Oxide Gas SterilizerFLF · Traditional | Andersen Sterilizers, Inc. | 10/31/2017SE |
| K150646 | EOGas 4 Ethylene Oxide Gas SterilizerFLF · Traditional | Andersen Sterilizers, Inc. | 11/18/2015SE |
| K142034 | 3M Steri-Vac Sterilizer/AeratorFLF · Abbreviated | 3M Company | 01/08/2015SE |
| K090636 | TSO3 Ozone Sterilizer, Model 125LFLF · Traditional | Tso3, Inc. | 12/02/2009SE |
| K051595 | TSO3 Ozone Sterilizer, Model 125LFLF · Traditional | Tso3, Inc. | 07/26/2006SE |
| K020875 | TSO3 Ozone Sterilizer, Model 125LFLF · Traditional | Technologies of Sterilization With Oxone, Tso3… | 08/26/2003SE |
| K014013 | H & W Hospital Ethylene Oxide Sterilizer Control SystemFLF · Abbreviated | H & W Technology, LLC | 06/25/2003SE |
| K923442 | Abtox Plazlyte Process MonitorFLF · Traditional | Abtox, Inc. | 12/22/1994SE |
| K905119 | Plazlyte(Tm)FLF · Traditional | Abtox, Inc. | 12/22/1994SE |
More from Abtox, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252843 | STERRAD 100NX Sterilization System with ALLClear Technology (10104)MLR · Traditional | 04/15/2026SE |
| K250802 | STERRAD® 100NX Sterilizer with ALLClear Technology (10104)MLR · Traditional | 04/14/2025SE |
| K234084 | STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator…JOJ · Traditional | 07/05/2024SE |
| K234082 | STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104)…MLR · Traditional | 07/05/2024SE |
| K220404 | STERRAD NX with ALLClear TechnologyMLR · Traditional | 05/16/2022SE |
| K212174 | STERRAD 100NX Sterilizer with ALLClear TechnologyMLR · Traditional | 10/09/2021SE |
| K163598 | Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD…KCT · Traditional | 07/31/2017SE |
| K162007 | STERRAD NX SterilizerMLR · Special | 02/16/2017SE |
| K160818 | STERRAD® NX Sterilizer with ALLClear TechnologyMLR · Traditional | 09/27/2016SE |
| K160903 | STERRAD 100NX Sterilizer with ALLClearTM TechnologyMLR · Traditional | 09/26/2016SE |
Questions and answers
When was Sterrad 50 & Sterrad 100S Sterilizers cleared by the FDA?
Sterrad 50 & Sterrad 100S Sterilizers (K023290) received a 510(k) decision of Substantially Equivalent on April 3, 2003, 183 days after the submission was received.
What is the product code of K023290?
The FDA product code is FLF – Sterilizer, Ethylene-Oxide Gas, a Class II (moderate risk) device regulated under 21 CFR 880.6860.