510(k) · Cleared
Recalled · Class II · 2013System 1.5 Sterile Processing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · MED Sterilant, Medical Devices
Cleared on Apr 5, 2010 as substantially equivalent to K875280 (Steris C/O Medical Device Consultants, Inc., 1988) and 1 other predicate after a 454-day review. Its family tree reaches back 3 generations to 1988. 4 later devices descend from it. It has been recalled 6 times.
- Decided
- Apr 5, 2010
- Review
- 454 days
- Class
- Class II
- Product code
- MED
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 3 generations to K875280 (1988). 7 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK875280 Steris System 1 Processor and 20 SterilantSteris C/O Medical Device Consultants, Inc. · 1988 · Recalled
- 2 generations backK972708 Endo-Spor Plus / HyprocideCottrell, Ltd. · 1999
- 1 generation backK013280 Sterilox Liquid Chemical Sterilant SystemSterilox Technologies, Inc. · 2002
- This deviceK090036 System 1.5 Sterile Processing SystemSTERIS Corporation · 2010
- Descendant · cites it directly · 3 of its ownK101409 System IE Liquid Chemical Cterilant Processing SystemSTERIS Corporation · 2010 · Recalled
- Descendant · cites it directly · 2 of its ownK102462 System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2010 · Recalled
- Descendant · cites it directly · 1 of its ownK113520 System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2012 · Recalled
- Descendant · cites it directly · 0 of its ownK131078 System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2013 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K101409System IE Liquid Chemical Cterilant Processing SystemSTERIS Corporation · 2010 · cites it directly3descendants
- K102462System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2010 · cites it directly2descendants
- K113520System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2012 · cites it directly1descendant
- K131078System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K875280 | Steris System 1 Processor and 20 Sterilant | Steris C/O Medical Device Consultants, Inc. | 1988 | 3 |
| −2 | K972708 | Endo-Spor Plus / Hyprocide | Cottrell, Ltd. | 1999 | — |
| −1 | K013280 | Sterilox Liquid Chemical Sterilant System | Sterilox Technologies, Inc. | 2002 | — |
| 0 (this device) | K090036 | System 1.5 Sterile Processing System | STERIS Corporation | 2010 | — |
| +1 | K101409 | System IE Liquid Chemical Cterilant Processing System | STERIS Corporation | 2010 | 4 |
| +1 | K102462 | System 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2010 | 5 |
| +1 | K113520 | System 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2012 | 2 |
| +1 | 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 |
|---|---|---|
| 2010 | 2 | 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? (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 |
|---|---|---|---|
| * | K875280 | Steris System 1 Processor and 20 SterilantSummary page 3…ication Number: 21 CFR 880.6885 Product Code: MED 2. Predicate Device STERIS SYSTEM I PROCESSOR and STERIS 20 STERILANT, K875280, cleared September 13, 1988. Sterilox Liquid Chemical High Level Disinfection System, K01 3280, cleared Sep… | 1988 |
| * | K013280 | Sterilox Liquid Chemical Sterilant SystemSummary page 3…e STERIS SYSTEM I PROCESSOR and STERIS 20 STERILANT, K875280, cleared September 13, 1988. Sterilox Liquid Chemical High Level Disinfection System, K01 3280, cleared September 18, 2002 3, Description of Device The SYSTEM I E Liquid Chemical Sterilant Processing Sys… | 2002 |
What descends from it? (4)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 21, 2013 | Class II | Z-0616-2014 | Device Design | Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts. |
| Aug 10, 2012 | Class II | Z-2284-2012 | Device Design | STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick connect. Due to the… |
| Aug 1, 2012 | Class II | Z-2335-2012 | Nonconforming Material/Component | The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property. |
| Dec 7, 2011 | Not classified | Z-0869-2012 | Software design | Software deficiency. STERIS identified that water specifications were not being met at some of their customer sites. Critical parameters for initiating cycles are: water quality, water pressure and water temperature. Failure to meet these… |
| Aug 11, 2011 | Not classified | Z-3124-2011 | Other | STERIS learned that SYSTEM 1E users may experience aborted cycles due to a failure within the UV light system. |
| Mar 14, 2011 | Not classified | Z-1960-2011 | Other | The printout, display and Operator Manual for the STERIS System 1E Liquid Chemical Sterilant Processing System are subject to recall/correction by the firm because in the event of an incomplete or aborted cycle, the language of the… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K101409 (STERIS Corporation, 2010) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K875280.
How does its category compare?
All MED devicesMED Sterilant, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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?
The SYSTEM IE Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities. The SYSTEM IE Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46 to 550C, and rinses the load with…
Read the full statement (192 words)
The SYSTEM IE Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities.
The SYSTEM IE Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46 to 550C, and rinses the load with extensively treated* potable water. The processed load should be used immediately.
The SYSTEM I E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
*The extensive treatment of EPA potable water consists of:
1. Pre-filtration through two pre-filters:
* Pre-filter I is a gross depth filter that removes approximately 5 micron or larger particles/contaminants.
* Pre-filter 2 is a surface filter that removes particles/contaminants > 0.1I micron.
2. UV Irradiation:
*During transit through the UV Water Treatment Chamber, a UV dose sufficient to achieve a >6-log reduction of MS2 virus is delivered to the water.
3. 0.1I micron filtration:
* The water prepared by pre-filtration and UV irradiation is filtered through redundant, 0.1I-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1I micron.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090036 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090036: System 1.5 Sterile Processing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090036
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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