510(k) Report

510(k) · Cleared

Cleared

System 1 endo Liquid Chemical Sterilant Processing System

K173256510(k) TraditionalCleared Mar 2, 2018143-day reviewClass II21 CFR 880.6885

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

STERIS Corporation · MED Sterilant, Medical Devices

Cleared on Mar 2, 2018 as substantially equivalent to K170956 (STERIS Corporation, 2017) after a 143-day review. Its family tree reaches back 2 generations to 2016. 12 later devices descend from it.

Decided
Mar 2, 2018
Review
143 days
Class
Class II
Product code
MED
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K161683 (2016). 12 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2019: 4 descendants cleared2021: 2 descendants cleared2023: 3 descendants cleared2022: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedK161683 · SYSTEM 1E Liquid Chemical Sterilant Processing System · STERIS Corporation · 2016K170956 · SYSTEM 1E Liquid Chemical Sterilant Processing System · STERIS Corporation · 2017201620182020202220242026
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 3 descendants5 generations forward: 3 descendants K170956 · SYSTEM 1E Liquid Chemical Sterilant Processing System · STERIS Corporation · 2017K161683 · SYSTEM 1E Liquid Chemical Sterilant Processing System · STERIS Corporation · 20160+5
  1. Root · 2 generations backK161683 SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2016
  2. 1 generation backK170956 SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2017
  3. This deviceK173256 System 1 endo Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2018
  4. Descendant · cites it directly · 10 of its ownK182827 SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900STERIS Corporation · 2019
  5. Descendant · 2 generations on · 9 of its ownK191343 SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900STERIS Corporation · 2019
  6. Descendant · cites it directly · 9 of its ownK190104 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo…Steris Corporations · 2019
  7. Descendant · cites it directly · 8 of its ownK192929 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2019
  8. Descendant · 2 generations on · 7 of its ownK210737 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2021

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2019: 42021: 22022: 12023: 32024: 12026: 1
2019high 4 (2019) · low 0 (2020)2026

Most influential descendants

Showing 5 of 12 · See all
  • K182827SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900STERIS Corporation · 2019 · cites it directly10descendants
  • K191343SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900STERIS Corporation · 2019 · 2 generations on9descendants
  • 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 · cites it directly8descendants
  • K210737SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…STERIS Corporation · 2021 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K161683SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation2016—
−1K170956SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation2017—
0 (this device)K173256System 1 endo Liquid Chemical Sterilant Processing SystemSTERIS Corporation2018—
+1K182827SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900STERIS Corporation2019—
+2K191343SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900STERIS Corporation2019—
+1K190104SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid…Steris Corporations2019—
+1K192929SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid…STERIS Corporation2019—
+2K210737SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid…STERIS Corporation2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201940
202120
202210
202330
202410
202610
FIG. 1 — Lineage of K173256, 2016–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251666 SYSTEM 1E Liquid Chemical Sterilant Processing…score 13.8 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K170956SYSTEM 1E Liquid Chemical Sterilant Processing System
Summary page 5
…MED 2. Predicate Device The claimed primary predicate device is the SYSTEM 1E Liquid Chemical Sterilant Processing System, cleared most recently under K170956. The S1E prior clearances include Premarket submissions K090036, K101409, K102462, K110352, K131078, K161683. 3. Des…
STERIS Corporation2017—

Also cleared against K170956: 1 other device →

What descends from it? (12)

See all 12

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K182827SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900STERIS Corporation201910
K190104SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical…Steris Corporations20199
K192929SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…STERIS Corporation20198

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 1 company; a new generation was cleared every 1.1 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K182827 (STERIS Corporation, 2019) has gone furthest, with 10 descendants of its own.
  • 1 other device also cites its predicate K170956.

How does its category compare?

All MED devices

MED 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

2007: 22008: 12010: 62012: 32013: 12014: 12016: 12017: 12018: 22019: 42021: 22022: 12023: 22026 (partial year): 2
2007high 6 (2010) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MED

84in 2019

2010: 281 days median2012: 111 days median2019: 84 days median
2007high 281 (2010) · low 84 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MED

2in 2011

2007: 32008: 22011: 2
2007high 3 (2007) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MED

9in 2025

2007: 342008: 792009: 1582010: 892011: 1062012: 3372013: 1402014: 1052015: 1102016: 1352017: 742018: 422019: 352020: 322021: 312022: 162023: 92024: 82025: 9
2007high 337 (2012) · low 8 (2024)2025

MAUDE reports naming product code MED, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—334
20081—279
20090—0158
20106281089
20110—2106
201231110337
20131—0140
20141—0105
20150—0110
20161—0135
20171—074
20182—042
2019484035
20200—032
20212—031
20221—016
20232—09
20240—08
20250—09
20262—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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K170956

1 other device cites the same predicate.

  • K180342SYSTEM 1E Liquid Chemical Sterilant Processing SystemSteris Corporations · 2018

More from STERIS Corporation

205 FDA decisions under this applicant name. See the company

  • K261055AMSCO 700 Steam SterilizerSTERIS Corporation · 2026
  • K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant…STERIS Corporation · 2026
  • K260766Celerity 5 HP Biological Indicator (LCB052)STERIS Corporation · 2026
  • K252680Celerity™ 20 HP Biological IndicatorSTERIS Corporation · 2025
  • K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation · 2025

Recent decisions in MED

The MED category page

  • K254094Endox High Level DisinfectantWhiteley USA, Inc. · 2026
  • K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant…STERIS Corporation · 2026
  • K232914SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant…STERIS Corporation · 2023
  • K230582SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900STERIS Corporation · 2023
  • K222615SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing…STERIS Corporation · 2022

https://510kreport.com/device/K173256 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173256: System 1 endo 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/K173256

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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