# K972747: BI-O.K. EO Gas Biological Test-Pak (269305,269310,269320)

- Pathway: 510(k) (Traditional)
- Applicant: Propper Mfg. Co., Inc.
- Decided: Jan 9, 1998 after 170 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) AAMI standard pack: named in the summary without a submission number
- (no number) 3M test packs: named in the summary without a submission number
- (no number) ATI test packs: named in the summary without a submission number

## Indications for use
The Propper BI-O.K. Gas Biological Test Pack is indicated for use as an aid or adjunct for use in biological monitoring of ethylene oxide sterilizers only. Its performance was verified versus the standard AAMI pack under the conditions of 600 mg/L ethylene oxide, 60% RH, 54.4 C in a Joslyn BIER vessel using a 10% ethylene oxide, 90% HCFC gas

Source page: https://510kreport.com/device/K972747
Methodology: https://510kreport.com/methodology