Sterizone Self-Contained Biological Indicator
FDA 510(k) K141580 · Tso3, Inc.
510(k) numberK141580
Submission
- Device name
- Sterizone Self-Contained Biological Indicator
- Applicant
- Tso3, Inc.
Vancouver, WA, US - Received
- June 13, 2014
- Decision date
- December 17, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRC – Indicator, Biological Sterilization Process
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
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| K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator…FRC · Traditional | Terragene S.A. | 12/12/2024SE |
| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 3M Company | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 3M Company | 10/18/2024SE |
More from 3M Company
| 510(k) | Device | Decision |
|---|---|---|
| K190260 | STERIZONE(R) VP4 SterilizerPJJ · Traditional | 07/19/2019SE |
| K172191 | STERIZONE VP4 SterilizerPJJ · Traditional | 05/09/2018SE |
| K173694 | STERIZONE VP4 SterilizerPJJ · Traditional | 03/13/2018SE |
| K153689 | STERIZONE SterilizerPJJ · Traditional | 06/30/2016SE |
| K141698 | Sterizone Chemical IndicatorJOJ · Traditional | 12/17/2014SE |
| K141163 | Sterizone SterilizerPJJ · Traditional | 12/17/2014SE |
| K090636 | TSO3 Ozone Sterilizer, Model 125LFLF · Traditional | 12/02/2009SE |
| K080198 | TSO3 Ozone Sterilization WrapFRG · Traditional | 05/30/2008SE |
| K051595 | TSO3 Ozone Sterilizer, Model 125LFLF · Traditional | 07/26/2006SE |
Questions and answers
When was Sterizone Self-Contained Biological Indicator cleared by the FDA?
Sterizone Self-Contained Biological Indicator (K141580) received a 510(k) decision of Substantially Equivalent on December 17, 2014, 187 days after the submission was received.
What is the product code of K141580?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.