# K020205: Castle Peracetic Acid Biological Indicator Kit

- Pathway: 510(k) (Traditional)
- Applicant: Getinge/Castle, Inc.
- Decided: Jun 24, 2002 after 153 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: 2 generations back to K792649 (1980). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960777: MDT Unispore and Spor-Test Biologicalindicator, Mdt Corp., Inc. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K960570: Steris Process Biological Indicator Kit. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K043135: Spsmedical Sporview PA Culture Set (2005), 1 descendant of its own
- K081879: Spsmedical Sporview PA Culture Set (2008), 0 descendants of its own
- K050664: Spor-Test PA Biological Indicator Kit (2005), 0 descendants of its own

## Indications for use
The Castle SPOR-TEST PA Biological Indicator Kit is only intended to monitor the Steris System 1 liquid chemical sterilization system, with the Steris 20 sterilant. Use in monitoring other sterilization processes is contraindicated. Castle SPOR-TEST PA Biological Indicators are qualified using Castle Culture Media. When tested at 1,000 ppm peracetic acid, 50°C, the Castle SPOR-TEST PA Biological Indicator will survive at 41 seconds and will be killed at 6 minutes.

Source page: https://510kreport.com/device/K020205
Methodology: https://510kreport.com/methodology