510(k) · Cleared
ClearedSYSTEM 1E Liquid Chemical Sterilant Processing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steris Corporations · MED Sterilant, Medical Devices
Cleared on Apr 4, 2018 as substantially equivalent to K170956 (STERIS Corporation, 2017) after a 56-day review. Its family tree reaches back 2 generations to 2016. 10 later devices descend from it.
- Decided
- Apr 4, 2018
- Review
- 56 days
- Class
- Class II
- Product code
- MED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K161683 (2016). 10 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK161683 SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2016
- 1 generation backK170956 SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2017
- This deviceK180342 SYSTEM 1E Liquid Chemical Sterilant Processing SystemSteris Corporations · 2018
- Descendant · cites it directly · 9 of its ownK190104 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo…Steris Corporations · 2019
- Descendant · 2 generations on · 8 of its ownK192929 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2019
- Descendant · 3 generations on · 7 of its ownK210737 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2021
- Descendant · 4 generations on · 6 of its ownK211607 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2021
- Descendant · 5 generations on · 3 of its ownK222615 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2022
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K190104SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical…Steris Corporations · 2019 · cites it directly9descendants
- K192929SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…STERIS Corporation · 2019 · 2 generations on8descendants
- K210737SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…STERIS Corporation · 2021 · 3 generations on7descendants
- K211607SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…STERIS Corporation · 2021 · 4 generations on6descendants
- K222615SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…STERIS Corporation · 2022 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K161683 | SYSTEM 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2016 | — |
| −1 | K170956 | SYSTEM 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2017 | — |
| 0 (this device) | K180342 | SYSTEM 1E Liquid Chemical Sterilant Processing System | Steris Corporations | 2018 | — |
| +1 | K190104 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid… | Steris Corporations | 2019 | — |
| +2 | K192929 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid… | STERIS Corporation | 2019 | — |
| +3 | K210737 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid… | STERIS Corporation | 2021 | — |
| +4 | K211607 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid… | STERIS Corporation | 2021 | — |
| +5 | K222615 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid… | STERIS Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K170956 | SYSTEM 1E Liquid Chemical Sterilant Processing SystemSummary page 5…ber: 21 CFR 880.6885 Product Code: MED 2. Predicate Device SYSTEM 1E Liquid Chemical Sterilant Processing System cleared under K170956 3. Description of Device The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilizat… | 2017 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190104 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical… | 2019 | 9 |
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 2 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K190104 (Steris Corporations, 2019) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K170956.
How does its category compare?
All MED devicesMED Sterilant, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 45.5 to 60°C, and rinses the load with…
Read the full statement (232 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 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use.
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 A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants.
• Pre-filter B 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/K180342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180342: 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/K180342
Report an extraction error
Are you the manufacturer?
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