510(k) · Cleared
Recalled · Class II · 2013Smart-Read Eztest-Steam Scbi and Test Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sgm Biotech, Inc. · FRC Indicator, Biological Sterilization Process
Cleared on May 14, 2010 as substantially equivalent to K930682 (Sgm Biotech, Inc., 1994) and 1 other predicate after a 155-day review. Its family tree reaches back 2 generations to 1980. 1 later device descends from it. It has been recalled 2 times.
- Decided
- May 14, 2010
- Review
- 155 days
- Class
- Class II
- Product code
- FRC
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K801109 (1980). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK801109 Proof (Biological/Chemical Indicator)Amsco Co. · 1980
- 1 generation backK963841 EztestSgm Biotech, Inc. · 1997 · Recalled
- This deviceK093794 Smart-Read Eztest-Steam Scbi and Test PackSgm Biotech, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK112018 Smart Read Eztest SteamMesa Laboratories, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K112018Smart Read Eztest SteamMesa Laboratories, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K801109 | Proof (Biological/Chemical Indicator) | Amsco Co. | 1980 | — |
| −1 | K963841 | Eztest | Sgm Biotech, Inc. | 1997 | 1 |
| 0 (this device) | K093794 | Smart-Read Eztest-Steam Scbi and Test Pack | Sgm Biotech, Inc. | 2010 | — |
| +1 | K112018 | Smart Read Eztest Steam | Mesa Laboratories, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K930682 | Eztest-SteamSummary page 1…ICATION: Class 11(General Hospital/General Controls) SUBSTANTIALLY EQUIVALENT OT THE FOLLOWING LEGALLY MARKETED DEVICES: EZTest® - steam - SCM Biotech, Inc. (K930682) EZTest® - steam - SGM Biotech, Inc. (K963841) [as required by Section 807.92(a)(3)]… | 1994 |
| * | K963841 | EztestSummary page 1…BSTANTIALLY EQUIVALENT OT THE FOLLOWING LEGALLY MARKETED DEVICES: EZTest® - steam - SCM Biotech, Inc. (K930682) EZTest® - steam - SGM Biotech, Inc. (K963841) [as required by Section 807.92(a)(3)]… | 1997 |
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 |
|---|---|---|---|
| K112018 | Smart Read Eztest Steam | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 2, 2013 | Class II | Z-1994-2013 | Other | AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. This could result in a false negative (or pass) when exposed to sub-lethal sterilization parameters. |
| Jun 4, 2013 | Class II | Z-1868-2013 | Nonconforming Material/Component | Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 16.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K112018 (Mesa Laboratories, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K930682.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Smart-Read EZTest - Steam self-contained biological indicators (SCBI) are for monitoring the efficacy of saturated steam sterilization processes. Performance characteristics are established in accordance with USP 31 for the pre-vacuum 121'C steam process. Additional pre-vacuum saturated steam sterilization temperatures are also included in the Certificate of Analysis. Smart-Read EZTest - steam SCB1s are also appropriate for use in saturated steam…
Read the full statement (279 words)
Smart-Read EZTest - Steam self-contained biological indicators (SCBI) are for monitoring the efficacy of saturated steam sterilization processes. Performance characteristics are established in accordance with USP 31 for the pre-vacuum 121'C steam process. Additional pre-vacuum saturated steam sterilization temperatures are also included in the Certificate of Analysis. Smart-Read EZTest - steam SCB1s are also appropriate for use in saturated steam processes of 1320 C, 1340 C and 1350 C.
The Smart-Read EZTest - steam SCSIl is placed into a sterilizer load in a horizontal position in a location that is judged to be the most difficult to sterilize. A sterilization cycle appropriate for the particular type of load is run. Following the sterilization cycle, the operator removes the SCBI from the load and waits approximately 10 minutes until the device has cooled so it can be comfortably handled. The operator then activates the self-contained ampoule by placing it into the activation well in the Smart-Well incubator and gently pulling forward. This action mechanically flexes the side wall of the plastic vial to break the glass ampoule containing the culture medium. The activated Smart-Read EZTest - steam SCSI is then placed in an incubator at 60 + 20 C for 10 hours which provides conditions conducive to growth of any bacterial spores which might have survived the sterilization cycle. Microbial growth of the indicator organisms will produce acid in the microbiological culture medium containing bromcresol purple, thus lowering the pH of the solution and invoking a yellow color change of the media components. If sterilization conditions are met the spores have been killed and the media will remain clear and purple at the conclusion of the 10 hour incubation time.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093794 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093794: Smart-Read Eztest-Steam Scbi and Test Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093794
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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