# K841168: Sterilization Process Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Parke-Davis Co.
- Decided: May 9, 1984 after 51 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041017: Spsmedical Airview Bowie Dick Test Pack (2004), 2 descendants of its own
- K130211: Airview Bowie Dick; Test Pack, Indicator Sheets (2013), 1 descendant of its own
- K093199: 3M Comply Bowie- Dick Type Lead Free Test Pack (2009), 1 descendant of its own
- K143629: U&U Bowie-Dick Test Pack (2015), 0 descendants of its own
- K133204: Airview Mini Owie Dick Test Pack (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K841168
Methodology: https://510kreport.com/methodology