Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)
FDA 510(k) K242453 · Terragene S.A.
510(k) numberK242453
Submission
- Device name
- Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)
- Applicant
- Terragene S.A.
Alvear, AR - Received
- August 19, 2024
- Decision date
- December 12, 2024
- 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 |
| 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 |
| K231383 | Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova®…FRC · Traditional | Terragene S.A. | 09/18/2024SE |
More from Terragene S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K231383 | Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova®…FRC · Traditional | 09/18/2024SE |
| K232103 | Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye®…QKM · Traditional | 04/05/2024SE |
| K221641 | Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper…FRC · Traditional | 02/28/2023SE |
| K200272 | Terragene ChemdyeJOJ · Traditional | 06/30/2020SE |
| K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene…FRC · Traditional | 09/13/2019SE |
| K163646 | Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD…FRC · Traditional | 11/02/2017SE |
Questions and answers
When was Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) cleared by the FDA?
Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) (K242453) received a 510(k) decision of Substantially Equivalent on December 12, 2024, 115 days after the submission was received.
What is the product code of K242453?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.