510(k) Report

510(k) · Cleared

Recalled · 2008

Steris System 1 Processor and 20 Sterilant

K875280510(k) TraditionalCleared Sep 13, 1988264-day reviewClass II21 CFR 880.6885Recalls 3

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

Steris C/O Medical Device Consultants, Inc. · MED Sterilant, Medical Devices

Cleared on Sep 13, 1988 after a 264-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it. It has been recalled 3 times.

Decided
Sep 13, 1988
Review
264 days
Class
Class II
Product code
MED
Recalls
3
Predicates
0

11 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2010: 3 descendants cleared1999: 1 descendant cleared2006: 1 descendant cleared2002: 1 descendant cleared2005: 1 descendant cleared2007: 1 descendant cleared2011: 1 descendant cleared2012: 1 descendant cleared2013: 1 descendant cleared1990200020102020
  1. This deviceK875280 Steris System 1 Processor and 20 SterilantSteris C/O Medical Device Consultants, Inc. · 1988
  2. Descendant · cites it directly · 7 of its ownK972708 Endo-Spor Plus / HyprocideCottrell, Ltd. · 1999
  3. Descendant · cites it directly · 6 of its ownK013280 Sterilox Liquid Chemical Sterilant SystemSterilox Technologies, Inc. · 2002
  4. Descendant · cites it directly · 4 of its ownK090036 System 1.5 Sterile Processing SystemSTERIS Corporation · 2010 · Recalled
  5. Descendant · 2 generations on · 3 of its ownK101409 System IE Liquid Chemical Cterilant Processing SystemSTERIS Corporation · 2010 · Recalled
  6. Descendant · 2 generations on · 2 of its ownK102462 System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2010 · Recalled

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

1999: 12002: 12005: 12006: 12007: 12010: 32011: 12012: 12013: 1
1999high 3 (2010) · low 0 (2000)2026

Most influential descendants

Showing 5 of 11 · See all
  • K972708Endo-Spor Plus / HyprocideCottrell, Ltd. · 1999 · cites it directly7descendants
  • K013280Sterilox Liquid Chemical Sterilant SystemSterilox Technologies, Inc. · 2002 · cites it directly6descendants
  • K090036System 1.5 Sterile Processing SystemSTERIS Corporation · 2010 · cites it directly4descendants
  • K101409System IE Liquid Chemical Cterilant Processing SystemSTERIS Corporation · 2010 · 2 generations on3descendants
  • K102462System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2010 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K875280Steris System 1 Processor and 20 SterilantSteris C/O Medical Device Consultants, Inc.1988—
+1K972708Endo-Spor Plus / HyprocideCottrell, Ltd.1999—
+1K013280Sterilox Liquid Chemical Sterilant SystemSterilox Technologies, Inc.2002—
+1K090036System 1.5 Sterile Processing SystemSTERIS Corporation20106
+2K101409System IE Liquid Chemical Cterilant Processing SystemSTERIS Corporation20104
+2K102462System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation20105

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200210
200510
200610
200710
201030
201110
201210
201310
FIG. 1 — Lineage of K875280, 1988–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K972708Endo-Spor Plus / HyprocideCottrell, Ltd.19997
K013280Sterilox Liquid Chemical Sterilant SystemSterilox Technologies, Inc.20026
K090036System 1.5 Sterile Processing SystemSTERIS Corporation20104
K060458Manzi Mach 1 Instrument Cleaner-Processor System, Manzi Detergent MD10, Manzi Sterilant…Langford IC Systems, Inc.20061
K032959Cidex Opa ConcentrateAdvanced Sterilization Products20050

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 4, 2008Not classifiedZ-2462-2008Device DesignDuring ongoing product development testing, it was discovered that, when the two inflow barbs on adapter 201048 # 4 are in a position to face one direction, the top Barblock may interfere with the top surface of bottom barb of the…
Mar 15, 2004Not classifiedZ-0765-04Process controlA defective port adapter may affect the sterilization process of the attached endoscope.
Mar 7, 2003Not classifiedZ-0547-03OtherThe Steris device may not attach properly to retrofitted Olympus bronchoscopes, and become loose during the sterile processing cycle.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K972708 (Cottrell, Ltd., 1999) has gone furthest, with 7 descendants of its own.

How does its category compare?

All MED devices

MED Sterilant, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

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/K875280 · printed Nov 6, 2026

Cite this page

510(k) Report. “K875280: Steris System 1 Processor and 20 Sterilant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K875280

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026