Verify Self-Contained Biological Indicator
FDA 510(k) K051056 · Albert Browne , Ltd.
510(k) numberK051056
Submission
- Device name
- Verify Self-Contained Biological Indicator
- Applicant
- Albert Browne , Ltd.
North Attleboro, MA, US - Received
- April 26, 2005
- Decision date
- October 20, 2005
- 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
Other 510(k)s with product code FRC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260766 | Celerity 5 HP Biological Indicator (LCB052)FRC · Special | STERIS Corporation | 04/08/2026SE |
| 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 |
More from 3M Company
| 510(k) | Device | Decision |
|---|---|---|
| K063285 | Reliance Ci Process IndicatorJOJ · Traditional | 01/12/2007SE |
| K061738 | Albert Browne Ltd. Verify Steam and Eo Load Record CardJOJ · Traditional | 08/25/2006SE |
| K053479 | Verify Dry Heat LabelJOJ · Traditional | 07/18/2006SE |
| K060066 | Verify 3-10 Min Flash IntegratorJOJ · Traditional | 03/24/2006SE |
| K060103 | Albert Browne Ltd. Verify Steam Value IndicatorsJOJ · Special | 03/07/2006SE |
| K051101 | Verify Flash IntegratorJOJ · Traditional | 12/06/2005SE |
| K032801 | Modified Browne Packaging and Label Steam Process IndicatorJOJ · Special | 10/17/2003SE |
| K002741 | Browne TST Single Use Bowie Dick/Integrator Test PackJOJ · Traditional | 07/03/2002SE |
| K002937 | TST Control Integrator for Steam SterilizersLRT · Traditional | 11/05/2001SE |
| K012335 | Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and Metricide Plus 30…JOJ · Traditional | 10/01/2001SE |
Questions and answers
When was Verify Self-Contained Biological Indicator cleared by the FDA?
Verify Self-Contained Biological Indicator (K051056) received a 510(k) decision of Substantially Equivalent on October 20, 2005, 177 days after the submission was received.
What is the product code of K051056?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.