# K112018: Smart Read Eztest Steam

- Pathway: 510(k) (Traditional)
- Applicant: Mesa Laboratories, Inc.
- Decided: Jan 30, 2012 after 200 days
- Product code: FRC (Indicator, Biological 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: 4 generations back to K801109 (1980). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041386: Raven Protest - Steam, Raven Biological Laboratories, Inc. (2004) Summary page 1.
- K082756: Raven Protest -  Steam Biological Indicator, Raven Biological Laboratories, Inc. (2009) Summary page 1.
- K093794: Smart-Read Eztest-Steam Scbi and Test Pack, Sgm Biotech, Inc. (2010) Summary page 1.

## Indications for use
Mesa Smart Read EZTest - Steam is a self-contained Biological Indicator intended for monitoring the efficacy of steam sterilization processes. The SC13I may be used in the following steam sterilization cyles: Cycle Type Cycle Temp Cycle Exposure Time Gravity 1210C 30 Minutes Gravity 1320C - 10 Minutes Flash Gravity. 132 0C 3 Minutes* Pre-Vac 1320C 4 Minutes Pre-Vac 135 0C 3 Minutes *Un'Apped nonporous devices only Mesa Smart Read EZTest has a validated reduced incubation time bf 10 hours.

Source page: https://510kreport.com/device/K112018
Methodology: https://510kreport.com/methodology