Unispore-Biological Indicators
FDA 510(k) K792649 · Castle Co.
510(k) numberK792649
Submission
- Device name
- Unispore-Biological Indicators
- Applicant
- Castle Co.
Mchenry, IL, US - Received
- December 21, 1979
- Decision date
- January 29, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K870975 | Modified Castle PowerclaveFLE · Traditional | 04/17/1987SE |
| K860263 | Castle 7538 Floor Loading WasherLDS · Traditional | 03/05/1986SE |
| K844089 | Castle 7515 Utensil/Glassware WasherLDS · Traditional | 01/14/1985SE |
| K834048 | Bovie Conductive Adhes-Disper-ElectroGEI · Traditional | 04/04/1984SE |
| K833074 | Castle Tec-Test S.M.A.R.T. PackJOJ · Traditional | 11/07/1983SE |
| K831595 | Castle Model 3341 & 3441 & 4141 Gas AerFLI · Traditional | 06/15/1983SE |
| K792660 | 1500 Eo Exhaust HoodFLF · Traditional | 01/29/1980SE |
| K790677 | Eo Evacuating System IFLI · Traditional | 05/07/1979SE |
| K781887 | 9100 Daystar and 9110 Orbiter PackageFSY · Traditional | 12/12/1978SE |
| K781484 | Castle Model 3146 Gas AeratorFLI · Traditional | 10/27/1978SE |
Questions and answers
When was Unispore-Biological Indicators cleared by the FDA?
Unispore-Biological Indicators (K792649) received a 510(k) decision of Substantially Equivalent on January 29, 1980, 39 days after the submission was received.
What is the product code of K792649?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.