510(k) · Cleared
ClearedSterrad 100NX 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 Dec 18, 2007 after a 196-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Dec 18, 2007
- Review
- 196 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK071537 Sterrad 100NX Test PackAdvanced Sterilization Products · 2007
- Descendant · cites it directly · 2 of its ownK111391 Sterrad (R) 100NX Duo Cycle Test PackAdvanced Sterilization Products · 2012
- Descendant · 2 generations on · 1 of its ownK141580 Sterizone Self-Contained Biological IndicatorTso3, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK203560 STERIZONE VP4 Test PackTso3 Inc., Now A Part of Stryker · 2021
- Descendant · cites it directly · 0 of its ownK130263 Sterrad 50/100S/200 Test PackAdvanced Sterilization Products · 2014
Most influential descendants
Showing 4 of 4 · See all- K111391Sterrad (R) 100NX Duo Cycle Test PackAdvanced Sterilization Products · 2012 · cites it directly2descendants
- K141580Sterizone Self-Contained Biological IndicatorTso3, Inc. · 2014 · 2 generations on1descendant
- K203560STERIZONE VP4 Test PackTso3 Inc., Now A Part of Stryker · 2021 · 3 generations on0descendants
- K130263Sterrad 50/100S/200 Test PackAdvanced Sterilization Products · 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) | K071537 | Sterrad 100NX Test Pack | Advanced Sterilization Products | 2007 | — |
| +1 | K111391 | Sterrad (R) 100NX Duo Cycle Test Pack | Advanced Sterilization Products | 2012 | — |
| +2 | K141580 | Sterizone Self-Contained Biological Indicator | Tso3, Inc. | 2014 | — |
| +3 | K203560 | STERIZONE VP4 Test Pack | Tso3 Inc., Now A Part of Stryker | 2021 | — |
| +1 | K130263 | Sterrad 50/100S/200 Test Pack | Advanced Sterilization Products | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 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? (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 |
|---|---|---|---|
| * | — | STERRAD NX Test Pack Named without a submission number | |
| * | — | STERRAD CycleSure Biological Indicator Named without a submission number |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K111391 (Advanced Sterilization Products, 2012) has gone furthest, with 2 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. 2007, 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 Test Pack is used for routine monitoring of the STERRAD® 100NX sterilization cycle and is also used for the periodic testing of a STERRAD® 100NX system using hospital-defined loads.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071537 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071537: Sterrad 100NX 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/K071537
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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