# K031152: Propper Vapor Line PCD (Steam Sterilization Process Challenge Test)

- Pathway: 510(k) (Traditional)
- Applicant: Propper Mfg. Co., Inc.
- Decided: Aug 17, 2004 after 494 days
- Product code: JOJ (Indicator, Physical/Chemical 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) Propper Bio-Challenge Test-Pak: named in the summary without a submission number

## Indications for use
The PROPPER VAPOR LINE PCD is indicated for use as a routine process challenge test for steam sterilizers in pre-vacuum cycles at 273.2 F/134°C.

Source page: https://510kreport.com/device/K031152
Methodology: https://510kreport.com/methodology