VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag
FDA 510(k) K182931 · Steris Corporations
510(k) numberK182931
Submission
- Device name
- VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag
- Applicant
- Steris Corporations
Mentor, OH, US - Received
- October 22, 2018
- Decision date
- November 20, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
More from 3M Company
| 510(k) | Device | Decision |
|---|---|---|
| K203630 | BioGuard Air/Water and Suction ValvesODC · Special | 01/08/2021SE |
| K190104 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical…MED · Special | 03/22/2019SE |
| K183295 | Celerity HP Chemical Indicator (CI)JOJ · Abbreviated | 01/04/2019SE |
| K183300 | VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator…FRC · Traditional | 01/03/2019SE |
| K180342 | SYSTEM 1E Liquid Chemical Sterilant Processing SystemMED · Special | 04/04/2018SE |
| K172748 | VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator…FRC · Traditional | 02/09/2018SE |
Questions and answers
When was VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag cleared by the FDA?
VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag (K182931) received a 510(k) decision of Substantially Equivalent on November 20, 2018, 29 days after the submission was received.
What is the product code of K182931?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.