510(k) · Cleared
ClearedSterrad (R) 100NX Duo Cycle Test Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Sterilization Products · FRC Indicator, Biological Sterilization Process
Cleared on Sep 26, 2012 as substantially equivalent to K071537 (Advanced Sterilization Products, 2007) after a 497-day review. Its family tree reaches back 1 generation to 2007. 2 later devices descend from it.
- Decided
- Sep 26, 2012
- Review
- 497 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071537 (2007). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK071537 Sterrad 100NX Test PackAdvanced Sterilization Products · 2007
- This deviceK111391 Sterrad (R) 100NX Duo Cycle Test PackAdvanced Sterilization Products · 2012
- Descendant · cites it directly · 1 of its ownK141580 Sterizone Self-Contained Biological IndicatorTso3, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK203560 STERIZONE VP4 Test PackTso3 Inc., Now A Part of Stryker · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071537 | Sterrad 100NX Test Pack | Advanced Sterilization Products | 2007 | — |
| 0 (this device) | K111391 | Sterrad (R) 100NX Duo Cycle Test Pack | Advanced Sterilization Products | 2012 | — |
| +1 | K141580 | Sterizone Self-Contained Biological Indicator | Tso3, Inc. | 2014 | — |
| +2 | K203560 | STERIZONE VP4 Test Pack | Tso3 Inc., Now A Part of Stryker | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K071537 | Sterrad 100NX Test PackSummary page 1…Classification Regulation: 21 CFR 880.2800 Proprietary Name: STERRAD® I100NX® DUO Cycle Test Pack 2. PREDICATE DEVICES STERRAD® IOONX® Test Pack, K07 1537 cleared on December 18, 2007 3. INDICATIONS FOR USE The STERRAD® 1OONX® DUO Cycle Test Pack is used for routine monitoring… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141580 | Sterizone Self-Contained Biological Indicator | 2014 | 1 |
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?
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 STERRAD® 100NX® DUO Cycle Test Pack is used for routine monitoring of the STERRAD® 100NX® DUO Sterilization Cycle and is also used for the periodic testing of a STERRAD® 100NX® System DUO Cycle, using hospital-defined loads containing devices that do not exceed claims of the cycle. The STERRAD® 100NX® DUO Cycle Test Pack consists of a STERRAD® CYCLESURE® 24 Biological Indicator, vial and cap to hold the BI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111391 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111391: Sterrad (R) 100NX Duo Cycle Test Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111391
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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