510(k) · Cleared
ClearedSmart-Well Incubator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mesa Laboratories, Inc. · FRC Indicator, Biological Sterilization Process
Cleared on Mar 26, 2013 after a 232-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Mar 26, 2013
- Review
- 232 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK122362 Smart-Well IncubatorMesa Laboratories, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK141238 Sterilucent Self-Contained Biological IndicatorSterilucent, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K141238Sterilucent Self-Contained Biological IndicatorSterilucent, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K122362 | Smart-Well Incubator | Mesa Laboratories, Inc. | 2013 | — |
| +1 | K141238 | Sterilucent Self-Contained Biological Indicator | Sterilucent, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRC device
- #1 K250044 Celerity 5 HP Biological Indicator (LCB052)…score 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141238 | Sterilucent Self-Contained Biological Indicator | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K141238 (Sterilucent, Inc., 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · FRC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRC
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRC
8so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRC
9in 2025
MAUDE reports naming product code FRC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 83 | 0 | 100 |
| 2008 | 1 | — | 0 | 60 |
| 2009 | 6 | 183 | 1 | 45 |
| 2010 | 4 | 165 | 0 | 57 |
| 2011 | 6 | 118 | 0 | 37 |
| 2012 | 9 | 178 | 2 | 46 |
| 2013 | 4 | 260 | 2 | 39 |
| 2014 | 13 | 174 | 0 | 51 |
| 2015 | 3 | 130 | 0 | 182 |
| 2016 | 2 | — | 0 | 482 |
| 2017 | 10 | 130 | 0 | 182 |
| 2018 | 18 | 97 | 0 | 22 |
| 2019 | 5 | 88 | 0 | 30 |
| 2020 | 10 | 150 | 0 | 16 |
| 2021 | 5 | 107 | 0 | 10 |
| 2022 | 5 | 193 | 4 | 9 |
| 2023 | 6 | 190 | 1 | 20 |
| 2024 | 8 | 105 | 0 | 22 |
| 2025 | 6 | 29 | 0 | 9 |
| 2026 | 1 | — | 8 | — |
What is it indicated for?
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…
Read the full statement (323 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K122362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122362: Smart-Well Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122362
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026