510(k) · Cleared
Recalled · Class II · 2015System 1E Liquid Chemical Sterilant 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 Jul 5, 2013 as substantially equivalent to K090036 (STERIS Corporation, 2010) and 3 other predicates after a 79-day review. Its family tree reaches back 7 generations to 1988. It has been recalled 2 times.
- Decided
- Jul 5, 2013
- Review
- 79 days
- Class
- Class II
- Product code
- MED
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 7 generations to K875280 (1988). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK875280 Steris System 1 Processor and 20 SterilantSteris C/O Medical Device Consultants, Inc. · 1988 · Recalled
- 6 generations backK972708 Endo-Spor Plus / HyprocideCottrell, Ltd. · 1999
- 5 generations backK013280 Sterilox Liquid Chemical Sterilant SystemSterilox Technologies, Inc. · 2002
- 4 generations backK090036 System 1.5 Sterile Processing SystemSTERIS Corporation · 2010 · Recalled
- 3 generations backK101409 System IE Liquid Chemical Cterilant Processing SystemSTERIS Corporation · 2010 · Recalled
- 2 generations backK102462 System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2010 · Recalled
- 1 generation backK113520 System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2012 · Recalled
- This deviceK131078 System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K875280 | Steris System 1 Processor and 20 Sterilant | Steris C/O Medical Device Consultants, Inc. | 1988 | 3 |
| −6 | K972708 | Endo-Spor Plus / Hyprocide | Cottrell, Ltd. | 1999 | — |
| −5 | K013280 | Sterilox Liquid Chemical Sterilant System | Sterilox Technologies, Inc. | 2002 | — |
| −4 | K090036 | System 1.5 Sterile Processing System | STERIS Corporation | 2010 | 6 |
| −3 | 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 |
| −1 | K113520 | System 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2012 | 2 |
| 0 (this device) | K131078 | System 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 3 | 0 |
| 1995 | 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? (4)
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 |
|---|---|---|---|
| * | K090036 | System 1.5 Sterile Processing SystemSummary page 2…ation Number: 21 CFR 880.6885 Product Code: MED 2. Predicate Device SYSTEM IE Liquid Chemical Sterilant Processing System (K090036, KIO0 1409, K102462, and KI 13520) 3. Description of Device The SYSTEM IE Liquid Chemical Sterilant Processin… | 2010 |
| * | K101409 | System IE Liquid Chemical Cterilant Processing SystemSummary page 2…viding equivalent water treatment performance, safety, and effectiveness to that described within K090036. This modification was subsequently cleared under K101409. Minor revisions to software that did not alter cycle parameters were cleared under K102462 and KI 13520. The SYST… | 2010 |
| * | K102462 | System 1E Liquid Chemical Sterilant Processing SystemSummary page 2…FR 880.6885 Product Code: MED 2. Predicate Device SYSTEM IE Liquid Chemical Sterilant Processing System (K090036, KIO0 1409, K102462, and KI 13520) 3. Description of Device The SYSTEM IE Liquid Chemical Sterilant Processing System is a liquid chemic… | 2010 |
| * | K113520 | System 1E Liquid Chemical Sterilant Processing System | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 4, 2015 | Class II | Z-1180-2016 | Nonconforming Material/Component | The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as indicated in the Quick Connect processing instructions. |
| 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 5 of the 11 ancestors have a recall of any class.
- 3 other devices also cite its predicate K090036.
How does its category compare?
All MED devicesMED Sterilant, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 1E 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 1E 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 55°C, and rinses the load with…
Read the full statement (186 words)
The SYSTEM 1E 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 1E 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 55°C, and rinses the load with extensively treated* potable water. The processed load should be used immediately.
The SYSTEM 1E 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 1 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 >0.1 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. 0.1 micron filtration:
*The water prepared by pre-filtration and UV irradiation is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa >0.1 micron.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131078: System 1E Liquid Chemical Sterilant Processing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131078
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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