510(k) · Cleared
ClearedAnprolene SteriTest
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Andersen Sterilizers, Inc. · FRC Indicator, Biological Sterilization Process
Cleared on Oct 31, 2017 as substantially equivalent to K151585 (Andersen Sterilizers, Inc., 2015) after a 260-day review. Its family tree reaches back 3 generations to 1980.
- Decided
- Oct 31, 2017
- Review
- 260 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K801109 (1980). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK801109 Proof (Biological/Chemical Indicator)Amsco Co. · 1980
- 2 generations backK930683 Eztest-GasSgm Biomedical, Inc. · 1997
- 1 generation backK151585 Andersen EOGas 4 SteriTestAndersen Sterilizers, Inc. · 2015
- This deviceK170427 Anprolene SteriTestAndersen Sterilizers, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801109 | Proof (Biological/Chemical Indicator) | Amsco Co. | 1980 | — |
| −2 | K930683 | Eztest-Gas | Sgm Biomedical, Inc. | 1997 | — |
| −1 | K151585 | Andersen EOGas 4 SteriTest | Andersen Sterilizers, Inc. | 2015 | — |
| 0 (this device) | K170427 | Anprolene SteriTest | Andersen Sterilizers, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K151585 | Andersen EOGas 4 SteriTestSummary page 4…Product Code FRC 5.5 Predicate Device Device Name EOGas 4® SteriTest, AN7408.14 510(k) number K151585 Manufacturer Mesa Laboratories, Inc. The predicate AN7408.14 EOGas 4 SteriTest (K151585) is appr… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 37 years and passes through 3 companies; a new generation was cleared every 16.8 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K151585.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Anprolene SteriTest consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated BI receptacle in the sterilizer. It monitors the efficacy of the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized in Table 1. Table 1. Critical sterilization cycle parameters in the Anprolene…
Read the full statement (93 words)
The Anprolene SteriTest consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated BI receptacle in the sterilizer. It monitors the efficacy of the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized in Table 1.
Table 1. Critical sterilization cycle parameters in the Anprolene AN75 Ethylene Oxide Gas Sterilizer
EO Amount Temperature Relative Humidity EO Exposure Time Total Cycle Time
17.6 g ± 5% 20-29°C 35-90% 12 hours 14 hours
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170427: Anprolene SteriTest.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170427
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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