STERRAD VELOCITY Biological Indictator and Reader
FDA 510(k) K170039 · Advanced Sterilization Products (Asp)
510(k) numberK170039
Submission
- Device name
- STERRAD VELOCITY Biological Indictator and Reader
- Applicant
- Advanced Sterilization Products (Asp)
Irvin, CA, US - Received
- January 5, 2017
- Decision date
- June 20, 2017
- 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 |
|---|---|---|
| K192025 | STERRAD VELOCITY Biological Indicator/Process Challenge Device and ReaderFRC · Traditional | 01/23/2020SE |
| K181472 | AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC MonitorFEB · Traditional | 04/23/2019SE |
| K182404 | STERRAD VELOCITY Biological IndicatorFRC · Traditional | 12/27/2018SE |
| K152189 | Evotech EcrFEB · Traditional | 07/20/2016SE |
Questions and answers
When was STERRAD VELOCITY Biological Indictator and Reader cleared by the FDA?
STERRAD VELOCITY Biological Indictator and Reader (K170039) received a 510(k) decision of Substantially Equivalent on June 20, 2017, 166 days after the submission was received.
What is the product code of K170039?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.