# K930682: Eztest-Steam

- Pathway: 510(k) (Traditional)
- Applicant: Sgm Biotech, Inc.
- Decided: Apr 4, 1994 after 418 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
0 of 14 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
- K963841: Eztest (1997), 12 descendants of its own
- K070595: Sporview Steam Self-Contained Biological Indicator (2007), 3 descendants of its own
- K111515: Spsmedical Sporview Steam BI (2012), 2 descendants of its own
- K071895: Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator (2007), 2 descendants of its own
- K041386: Raven Protest - Steam (2004), 2 descendants of its own

## Recalls of this device
- Jun 10, 2013 · Class II · Z-1824-2013: 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-1822-2013: 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-1823-2013: 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 4, 2013 · Class II · Z-1867-2013: Mesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.

Source page: https://510kreport.com/device/K930682
Methodology: https://510kreport.com/methodology