# K163144: gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)

- Pathway: 510(k) (Traditional)
- Applicant: Gke-GmbH
- Decided: Apr 7, 2017 after 149 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 3M™ Attest™ 1262/1262P (pre-amendment): named in the summary without a submission number

## Indications for use
The gke Steam SCBI is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of nominal 100,000 spores of Geobacillus stearothermophilus on a carrier and enclosed in a protective plastic vial. The spores have a known resistance to certain steam sterilization cycles. The device can be used for gravity and pre-vacuum cycles according to the following conditions: 121 °C, 30 minutes / 132, 134 and 135°C, 3 minutes. Subsequent growth or failure of the microorganisms after an incubation time of 24 hours at 55-60 °C indicates the adequacy of sterilization.

Source page: https://510kreport.com/device/K163144
Methodology: https://510kreport.com/methodology