Sporview Culture Media
FDA 510(k) K890754 · Spsmedical Supply Corp.
510(k) numberK890754
Submission
- Device name
- Sporview Culture Media
- Applicant
- Spsmedical Supply Corp.
Rochester, NY, US - Received
- February 14, 1989
- Decision date
- November 17, 1989
- 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
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| 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 |
|---|---|---|
| K122024 | Spsmedical Sporview 10 Steam Self Contained Biological IndicatorFRC · Traditional | 11/26/2013SE |
| K130211 | Airview Bowie Dick; Test Pack, Indicator SheetsJOJ · Special | 07/05/2013SE |
| K111515 | Spsmedical Sporview Steam BiFRC · Traditional | 02/01/2012SE |
| K110152 | Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsJOJ · Traditional | 04/15/2011SE |
| K102363 | Spsmedical Emplus 270 F Steam Emulator Model EMP-104, EMP-1004JOJ · Traditional | 01/27/2011SE |
| K090650 | Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsJOJ · Traditional | 10/09/2009SE |
| K081879 | Spsmedical Sporview Pa Culture SetMRB · Special | 07/30/2008SE |
| K070595 | Sporview Steam Self-Contained Biological IndicatorFRC · Traditional | 05/24/2007SE |
| K063799 | Steamplus Steam IntegratorJOJ · Traditional | 01/05/2007SE |
| K051173 | Spsmedical Sporview Plus Steam Bi Test PackFRC · Special | 05/27/2005SE |
Questions and answers
When was Sporview Culture Media cleared by the FDA?
Sporview Culture Media (K890754) received a 510(k) decision of Substantially Equivalent on November 17, 1989, 276 days after the submission was received.
What is the product code of K890754?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.