3M Steri-Vac Sterilizer/Aerator
FDA 510(k) K142034 · 3M Company
510(k) numberK142034
Submission
- Device name
- 3M Steri-Vac Sterilizer/Aerator
- Applicant
- 3M Company
St. Paul, MN, US - Received
- July 28, 2014
- Decision date
- January 8, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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
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|---|---|---|---|
| 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 |
| 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 |
| K023290 | Sterrad 50 & Sterrad 100S SterilizersFLF · Traditional | Advanced Sterilization Products | 04/03/2003SE |
| K923442 | Abtox Plazlyte Process MonitorFLF · Traditional | Abtox, Inc. | 12/22/1994SE |
| K905119 | Plazlyte(Tm)FLF · Traditional | Abtox, Inc. | 12/22/1994SE |
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| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 10/18/2024SE |
| K241710 | 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490…FRC · Traditional | 09/12/2024SE |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC · Special | 06/27/2024SE |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen…FRC · Special | 06/27/2024SE |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M…FRC · Traditional | 03/15/2024SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 05/18/2023SE |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 09/23/2022SE |
Questions and answers
When was 3M Steri-Vac Sterilizer/Aerator cleared by the FDA?
3M Steri-Vac Sterilizer/Aerator (K142034) received a 510(k) decision of Substantially Equivalent on January 8, 2015, 164 days after the submission was received.
What is the product code of K142034?
The FDA product code is FLF – Sterilizer, Ethylene-Oxide Gas, a Class II (moderate risk) device regulated under 21 CFR 880.6860.