Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles
FDA 510(k) K173626 · STERIS Corporation
510(k) numberK173626
Submission
- Device name
- Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles
- Applicant
- STERIS Corporation
Mentor, OH, US - Received
- November 24, 2017
- Decision date
- February 21, 2018
- 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 |
|---|---|---|
| K261055 | AMSCO 700 Steam SterilizerFLE · Traditional | 06/24/2026SE |
| K260766 | Celerity 5 HP Biological Indicator (LCB052)FRC · Special | 04/08/2026SE |
| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid…MED · Traditional | 04/08/2026SE |
| K252680 | Celerity 20 HP Biological IndicatorFRC · Special | 09/24/2025SE |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | 06/06/2025SE |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118JOJ · Special | 05/02/2025SE |
| K243876 | VERIFY STEAM Integrating IndicatorJOJ · Special | 04/25/2025SE |
| K250842 | PADLOCK CLIP EFTR Kit (00713229)PKL · Special | 04/18/2025SE |
| K242773 | Electro Lube NXTGEI · Traditional | 04/15/2025SE |
| K250061 | Celerity IncubatorFRC · Special | 02/06/2025SE |
Questions and answers
When was Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles cleared by the FDA?
Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles (K173626) received a 510(k) decision of Substantially Equivalent on February 21, 2018, 89 days after the submission was received.
What is the product code of K173626?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.