# K122362: Smart-Well Incubator

- Pathway: 510(k) (Special)
- Applicant: Mesa Laboratories, Inc.
- Decided: Mar 26, 2013 after 232 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K141238: Sterilucent Self-Contained Biological Indicator (2014), 0 descendants of its own

## Indications for use
The Smart-Well Model 1710 EZTest Incubator is intended for use with the Smart-Read EZTest Steam self-contained biological iridicator.(SCBI). When an activated Smart-Read EZTest Steam SCBI is placed into one of the incubation cavities the LED in front of the cavity will Illuminate amber, which indicates that the incubator electronically recognizes the Smart-Read EZTest Steam SCSI unit for incubation. Smart-Read EZTest is a Self-contained Biological Indicator (SCBI) intended for use in determining the efficacy of steam sterilization processes. The SCBI may be used in the following steam sterilization cycles: Cycle Type Cycle Temperature Cycle Exposure Time Gravity 121 C 30 minutes Gravity 1320C 10 minutes Flash Gravity 132C 3 minutes* Pre-Vac 1320C 4 minutes Pre-Vac 135C 3 minutes *Unwrapped nonporous devices only. Each incubation cavity also has an electronic monitoring system that detects if the BI is either purple or yellow. The Smart-Well Model 1710 EZTest Incubator can also be supplied with a printer which documents each individual Smart-Read EZTest Steam SCSI tested. The printer c 'an also display information that is normally manually entered into a log book. The printer can also be configured to display BI exposure information that includes SI Lot number, Sterilizer number, User identification and Cycle ID. If no selection is made for these options during the 61 Wizard set up. the printed report will print a'?* mark indicating no selection was made. The printed record will always indicate incubation cavity being reported, BI results (status). incubation start date and time when the SCSI was placed into the incubation cavity and the total time of incubation. The result options are 1) NEGATIVE (purple)-incubation time completed with no detectable color change in the Smart-Read EZTest unit, 2) POSITIVE (yellow)-time that a yellow color was detected in the Smart-Read EZTest unit, or 3) TESTING-when a printout is requested and event 1) or 2) have not happened. These results are easily verified by the user as performed inall conventional incubators without printers.

Source page: https://510kreport.com/device/K122362
Methodology: https://510kreport.com/methodology