Sterilucent Process Challenge Device
FDA 510(k) K141312 · Sterilucent, Inc.
510(k) numberK141312
Submission
- Device name
- Sterilucent Process Challenge Device
- Applicant
- Sterilucent, Inc.
Minneapolis, MN, US - Received
- May 20, 2014
- Decision date
- October 31, 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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| K251122 | Terragene® Bionova® BT20 Biological IndicatorFRC · Traditional | Terragene | 08/04/2025SE |
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| K243501 | 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest…FRC · Traditional | 3M Company | 01/28/2025SE |
| 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 |
|---|---|---|
| K192001 | Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process…FRC · Traditional | 10/22/2019SE |
| K191999 | Sterilucent VH2O2 Chemical IndicatorsJOJ · Traditional | 10/21/2019SE |
| K190005 | Sterilucent HC 80TT Hydrogen Peroxide SterilizerMLR · Traditional | 09/13/2019SE |
| K142109 | Sterilucent Sterilization Container SystemKCT · Traditional | 01/20/2015SE |
| K141238 | Sterilucent Self-Contained Biological IndicatorFRC · Traditional | 11/03/2014SE |
| K140464 | Sterilucent PSD-85 Hydrogen Peroxide SterilizerMLR · Traditional | 10/31/2014SE |
Questions and answers
When was Sterilucent Process Challenge Device cleared by the FDA?
Sterilucent Process Challenge Device (K141312) received a 510(k) decision of Substantially Equivalent on October 31, 2014, 164 days after the submission was received.
What is the product code of K141312?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.