# K982188: Steri-Pak Bowie Dick Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: Steritec Products Mfg Co, Inc.
- Decided: Nov 20, 1998 after 151 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K990246: Steri-Pak LF Bowie-Dick Test Pack (1999), 0 descendants of its own

## Recalls of this device
- Jun 17, 2020 · Class II · Z-2699-2020: The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use.

Source page: https://510kreport.com/device/K982188
Methodology: https://510kreport.com/methodology