510(k) · Cleared
ClearedSYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
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 Mar 28, 2023 as substantially equivalent to K222615 (STERIS Corporation, 2022) after a 26-day review. Its family tree reaches back 9 generations to 2016.
- Decided
- Mar 28, 2023
- Review
- 26 days
- Class
- Class II
- Product code
- MED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K161683 (2016). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK161683 SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2016
- 5 generations between
- 3 generations backK210737 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2021
- 2 generations backK211607 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2021
- 1 generation backK222615 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2022
- This deviceK230582 SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900STERIS Corporation · 2023
Show all 9 generations
- Root · 9 generations backK161683 SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2016
- 8 generations backK170956 SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2017
- 7 generations backK173256 System 1 endo Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2018
- 6 generations backK182827 SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900STERIS Corporation · 2019
- 5 generations backK191343 SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900STERIS Corporation · 2019
- 4 generations backK192929 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2019
- 3 generations backK210737 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2021
- 2 generations backK211607 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2021
- 1 generation backK222615 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2022
- This deviceK230582 SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900STERIS Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K161683 | SYSTEM 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2016 | — |
| −8 | K170956 | SYSTEM 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2017 | — |
| −7 | K173256 | System 1 endo Liquid Chemical Sterilant Processing System | STERIS Corporation | 2018 | — |
| −6 | K182827 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 | STERIS Corporation | 2019 | — |
| −5 | K191343 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 | STERIS Corporation | 2019 | — |
| −4 | 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 | — |
| −2 | K211607 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid… | STERIS Corporation | 2021 | — |
| −1 | K222615 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid… | STERIS Corporation | 2022 | — |
| 0 (this device) | K230582 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | STERIS Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K222615 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…Summary page 5…n Number: 21 CFR 880.6885 Product Code: MED 2. Predicate Device SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, K222615 3. Description of Device The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (S1 endo) is a liquid… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 1 company; a new generation was cleared every 7 months on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K222615.
How does its category compare?
All MED devicesMED Sterilant, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories in healthcare facilities.
The SYSTEM 1 endo Processor automatically 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 0.2 micron filtered water.
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230582 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230582: SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230582
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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