# K093199: 3M Comply Bowie- Dick Type Lead Free Test Pack

- Pathway: 510(k) (Special)
- Applicant: 3M Company
- Decided: Dec 4, 2009 after 56 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
Longest line of descent: 1 generation back to K841168 (1984). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K841168: Sterilization Process Indicator, Parke-Davis Co. (1984) Summary page 2.

## Most influential descendants
- K143629: U&U Bowie-Dick Test Pack (2015), 0 descendants of its own

## Indications for use
The 3M Comply Bowie-Dick Type Lead Free Test Pack is designed for testing air removal efficiency of 132-134°C (270-273°F) dynamic-air-removal steam sterilizers.

Source page: https://510kreport.com/device/K093199
Methodology: https://510kreport.com/methodology