510(k) · Cleared
ClearedSterilox Liquid Chemical Sterilant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilox Technologies, Inc. · MED Sterilant, Medical Devices
Cleared on Sep 18, 2002 as substantially equivalent to K923744 (Johnson & Johnson Medical, Inc., 1994) and 4 other predicates after a 351-day review. Its family tree reaches back 2 generations to 1988. 6 later devices descend from it.
- Decided
- Sep 18, 2002
- Review
- 351 days
- Class
- Class II
- Product code
- MED
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K875280 (1988). 6 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK875280 Steris System 1 Processor and 20 SterilantSteris C/O Medical Device Consultants, Inc. · 1988 · Recalled
- 1 generation backK972708 Endo-Spor Plus / HyprocideCottrell, Ltd. · 1999
- This deviceK013280 Sterilox Liquid Chemical Sterilant SystemSterilox Technologies, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK090036 System 1.5 Sterile Processing SystemSTERIS Corporation · 2010 · Recalled
- Descendant · 2 generations on · 3 of its ownK101409 System IE Liquid Chemical Cterilant Processing SystemSTERIS Corporation · 2010 · Recalled
- Descendant · 2 generations on · 2 of its ownK102462 System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK113520 System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK131078 System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2013 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K090036System 1.5 Sterile Processing SystemSTERIS Corporation · 2010 · cites it directly4descendants
- K101409System IE Liquid Chemical Cterilant Processing SystemSTERIS Corporation · 2010 · 2 generations on3descendants
- K102462System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2010 · 2 generations on2descendants
- K113520System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2012 · 2 generations on1descendant
- K131078System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K875280 | Steris System 1 Processor and 20 Sterilant | Steris C/O Medical Device Consultants, Inc. | 1988 | 3 |
| −1 | K972708 | Endo-Spor Plus / Hyprocide | Cottrell, Ltd. | 1999 | — |
| 0 (this device) | K013280 | Sterilox Liquid Chemical Sterilant System | Sterilox Technologies, Inc. | 2002 | — |
| +1 | K090036 | System 1.5 Sterile Processing System | STERIS Corporation | 2010 | 6 |
| +2 | K101409 | System IE Liquid Chemical Cterilant Processing System | STERIS Corporation | 2010 | 4 |
| +2 | K102462 | System 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2010 | 5 |
| +2 | K113520 | System 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2012 | 2 |
| +2 | K131078 | System 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2013 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 MED? 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 MED device
- #1 K251666 SYSTEM 1E Liquid Chemical Sterilant Processing…score 13.8 · 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? (5)
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 |
|---|---|---|---|
| * | K923744 | Cidex Plus 28 Day SolutionSummary page 2…mmercially available predicate devices - Cidex liquid chemical sterilants/disinfectants (K923744, K924334, K924434) Endo-Spor Plus/Hyprocide Liquid Chemical Sterilants (K972708)-… | 1994 |
| * | K924334 | Cidex Formula 7* Long-Life Activated DialdehydeSummary page 2…y available predicate devices - Cidex liquid chemical sterilants/disinfectants (K923744, K924334, K924434) Endo-Spor Plus/Hyprocide Liquid Chemical Sterilants (K972708)-… | 1994 |
| * | K924434 | Cidex Activated Dialdehyde SolutionSummary page 2…evices - Cidex liquid chemical sterilants/disinfectants (K923744, K924334, K924434) Endo-Spor Plus/Hyprocide Liquid Chemical Sterilants (K972708)-… | 1994 |
| * | K972708 | Endo-Spor Plus / HyprocideSummary page 2…Cidex liquid chemical sterilants/disinfectants (K923744, K924334, K924434) Endo-Spor Plus/Hyprocide Liquid Chemical Sterilants (K972708)- - Steris 20IM SterilanUSteris System 1 I M Proc… | 1999 |
| * | K875280 | Steris System 1 Processor and 20 SterilantSummary page 2…quid Chemical Sterilants (K972708)- - Steris 20IM SterilanUSteris System 1 I M Processor (K875280) These predicate devices are commercially available and marketed Unclassified and Class II devices indicated for us… | 1988 |
What descends from it? (6)
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K090036 (STERIS Corporation, 2010) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K923744.
How does its category compare?
All MED devicesMED Sterilant, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MED
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MED
84in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MED
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MED
9in 2025
MAUDE reports naming product code MED, 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 | 2 | — | 3 | 34 |
| 2008 | 1 | — | 2 | 79 |
| 2009 | 0 | — | 0 | 158 |
| 2010 | 6 | 281 | 0 | 89 |
| 2011 | 0 | — | 2 | 106 |
| 2012 | 3 | 111 | 0 | 337 |
| 2013 | 1 | — | 0 | 140 |
| 2014 | 1 | — | 0 | 105 |
| 2015 | 0 | — | 0 | 110 |
| 2016 | 1 | — | 0 | 135 |
| 2017 | 1 | — | 0 | 74 |
| 2018 | 2 | — | 0 | 42 |
| 2019 | 4 | 84 | 0 | 35 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 2 | — | 0 | 31 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 2 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Sterilox is a high level disinfectant system intended for processing heat-sensitive medical
devices when used according to the User Manual with an immersion time of ten (10)
minutes at 25°C. Sterilox is a single use product generated on site for use at its MRC of
650-675 ppm (AFC). Sterilox is intended for use with manual or automatic endoscope
reprocessing protocols.
This device is intended for use by qualified healthcare personnel trained in its use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013280 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013280: Sterilox Liquid Chemical Sterilant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013280
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026