# K990246: Steri-Pak LF Bowie-Dick Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: Steritec Products Mfg Co, Inc.
- Decided: Jun 10, 1999 after 135 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 K982188 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982188: Steri-Pak Bowie Dick Test Pack, Steritec Products Mfg Co, Inc. (1998) Summary page 1.

## Indications for use
The Steri-Pak LF Bowie Dick Test Pack manufactured by SteriTec Products Mfg. Co., Inc. is designed to detect the presence of residual air in prevacuum steam sterilizers operating at 132 °C. It is designed to be used for daily Bowie Dick testing of hospital sterilizers as described in AAMI/ANSI ST46 section 7.7. It contains no Lead.

Source page: https://510kreport.com/device/K990246
Methodology: https://510kreport.com/methodology