# K963841: Eztest

- Pathway: 510(k) (Traditional)
- Applicant: Sgm Biotech, Inc.
- Decided: Feb 25, 1997 after 153 days
- Product code: FRC (Indicator, Biological 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
Longest line of descent: 1 generation back to K801109 (1980). 3 ancestors in all.
12 later devices descend from it; 5 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930682: Eztest-Steam, Sgm Biotech, Inc. (1994) Summary page 2.
- K902344: Ati Disposable Biological Test Pack for Steam Ster, Ati (1990) Summary page 5.
- K801109: Proof (Biological/Chemical Indicator), Amsco Co. (1980) Summary page 2.
- (no number) Attest®: named in the summary without a submission number

## Most influential descendants
- 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
- K122024: Spsmedical Sporview 10 Steam Self Contained Biological Indicator (2013), 1 descendant of its own

## Recalls of this device
- 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.

## Indications for use
EZTest® - Steam self contained biological indicators are for monitoring the efficacy of saturated steam sterilization processors. Performance characteristics are established in accordance with USP XXiil for the 121 C - steam process. Additional saturated steam sterilization conditions are also included in the Certificate of Performance. EZTest® - Steam Bls are also appropriate for use in the high temperature saturated steam processes of 132C, 134 C and 135C.

Source page: https://510kreport.com/device/K963841
Methodology: https://510kreport.com/methodology