Self-Contained Biological Indicator
FDA 510(k) K200970 · True Indicating, LLC
510(k) numberK200970
Submission
- Device name
- Self-Contained Biological Indicator
- Applicant
- True Indicating, LLC
Toledo, OH, US - Received
- April 13, 2020
- Decision date
- December 28, 2020
- 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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| K252680 | Celerity 20 HP Biological IndicatorFRC · Special | STERIS Corporation | 09/24/2025SE |
| K251122 | Terragene® Bionova® BT20 Biological IndicatorFRC · Traditional | Terragene | 08/04/2025SE |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | Steris | 06/06/2025SE |
| K250061 | Celerity IncubatorFRC · Special | STERIS Corporation | 02/06/2025SE |
| K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | STERIS Corporation | 02/06/2025SE |
| 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 |
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|---|---|---|
| K251559 | InstaTRU Instant Biological Indicator for Steam (IBI-05)QVB · Traditional | 06/18/2026SE |
| K242860 | Type 5 Integrating Indicator for Steam (CSPN-15)JOJ · Traditional | 01/17/2025SE |
| K233413 | Ultraphon Chemical Indicator (TRO-T and TRO-B)JOJ · Traditional | 06/26/2024SE |
| K220778 | Chemical Indicator for SteamJOJ · Traditional | 12/02/2022SE |
| K210481 | Instant 20s IndicatorMTC · Traditional | 12/14/2021SE |
Questions and answers
When was Self-Contained Biological Indicator cleared by the FDA?
Self-Contained Biological Indicator (K200970) received a 510(k) decision of Substantially Equivalent on December 28, 2020, 259 days after the submission was received.
What is the product code of K200970?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.