# K001444: Steritec Steam Biological Test Pack with Instant Readout Integrator, Model BI 103

- Pathway: 510(k) (Special)
- Applicant: Steritec Products, Inc.
- Decided: May 15, 2000 after 7 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K022706: Spsmedical Sporview Steam BI Test Pack (2002), 2 descendants of its own
- K051173: Spsmedical Sporview Plus Steam BI Test Pack (2005), 1 descendant of its own
- K140620: Sporview Plus BI Test Pack (2014), 0 descendants of its own
- K031647: Biosign Ssi Biological Test Pack with Instant Readout Integrator (2003), 0 descendants of its own

## Recalls of this device
- Jun 10, 2013 · Class II · Z-1828-2013: Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specif
- Jun 10, 2013 · Class II · Z-1829-2013: Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specif

Source page: https://510kreport.com/device/K001444
Methodology: https://510kreport.com/methodology