# K242453: Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)

- Pathway: 510(k) (Traditional)
- Applicant: Terragene S.A.
- Decided: Dec 12, 2024 after 115 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K191021 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191021: Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye, Terragene S.A. (2019) Summary page 7.

## Indications for use
Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the ANSI/AAMI 16 towel pack. The device is intended for routine monitoring of the following steam sterilization processes: Dynamic-air-removal 132°C 4 minutes Dynamic-air-removal 135°C 3 minutes Gravity-displacement 132°C 25, 15, and 10 minutes Gravity-displacement 135°C 10 minutes Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the ANSI/AAMI 16 towel pack. The device is intended for routine monitoring of the following steam sterilization processes: Dynamic-air-removal 132°C 4 minutes Dynamic-air-removal 135°C 3 minutes Gravity-displacement 132°C 25, 15, and 10 minutes Gravity-displacement 135°C 10 minutes

Source page: https://510kreport.com/device/K242453
Methodology: https://510kreport.com/methodology