510(k) Report

510(k) · Cleared

Cleared

Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS)

K203061510(k) SpecialCleared Nov 6, 202029-day reviewClass II21 CFR 880.6880

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

STERIS Corporation · FLE Sterilizer, Steam

Cleared on Nov 6, 2020 as substantially equivalent to K173481 (STERIS Corporation, 2018) and 2 other predicates after a 29-day review. Its family tree reaches back 5 generations to 2001.

Decided
Nov 6, 2020
Review
29 days
Class
Class II
Product code
FLE
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K010865 (2001). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2018: 2 other ancestors2009: 1 other ancestorK010865 · Amsco Century Medium Sterilizer, Model Century · STERIS Corporation · 2001 · recalledK020747 · Amsco Century Medium Sterilizer 26 X 26 · STERIS Corporation · 2002K082435 · Amsco Evolution Medium Steam Sterilizer · STERIS Corporation · 2008 · recalledK091731 · Amsco Evolution Medium Steam Sterilizer · STERIS Corporation · 2009 · recalledK173490 · Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) · STERIS Corporation · 201820002005201020152020
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor K173490 · Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) · STERIS Corporation · 2018K091731 · Amsco Evolution Medium Steam Sterilizer · STERIS Corporation · 2009 · recalledK082435 · Amsco Evolution Medium Steam Sterilizer · STERIS Corporation · 2008 · recalledK020747 · Amsco Century Medium Sterilizer 26 X 26 · STERIS Corporation · 2002K010865 · Amsco Century Medium Sterilizer, Model Century · STERIS Corporation · 2001 · recalled−50
  1. Root · 5 generations backK010865 Amsco Century Medium Sterilizer, Model CenturySTERIS Corporation · 2001 · Recalled
  2. 4 generations backK020747 Amsco Century Medium Sterilizer 26 X 26STERIS Corporation · 2002
  3. 3 generations backK082435 Amsco Evolution Medium Steam SterilizerSTERIS Corporation · 2008 · Recalled
  4. 2 generations backK091731 Amsco Evolution Medium Steam SterilizerSTERIS Corporation · 2009 · Recalled
  5. 1 generation backK173490 Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)STERIS Corporation · 2018
  6. This deviceK203061 Amsco Evolution Medium Steam Sterilizer (Models HC-900 and…STERIS Corporation · 2020
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K010865Amsco Century Medium Sterilizer, Model CenturySTERIS Corporation20011
−4K020747Amsco Century Medium Sterilizer 26 X 26STERIS Corporation2002—
−3K082435Amsco Evolution Medium Steam SterilizerSTERIS Corporation20084
−2K091731Amsco Evolution Medium Steam SterilizerSTERIS Corporation20091
−1K173490Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)STERIS Corporation2018—
0 (this device)K203061Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution…STERIS Corporation2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200910
201820
FIG. 1 — Lineage of K203061, 2001–2020Source: 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 FLE? 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 FLE device

  1. #1 K250168 Life Ultra 25L Tabletop Mono Chamber Steam…score 12.7 · 8 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? (3)

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
*K173481Amsco Evolution Medium Steam Sterilizer
Summary page 16
…21 CFR 880.6880 Product Code: FLE, PEC 2. Predicate Device AMSCO Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200), K173481. 3. Description of Device The Amsco Evolution Medium Steam Sterilizer models HC-900 and HC-1200 are designed for st…
STERIS Corporation2018—
*K173485Amsco Evolution Medium Steam Sterilizer
Summary page 21
…21 CFR 880.6880 Product Code: FLE, PEC 8. Predicate Device AMSCO Evolution Medium Steam Sterilizer (Models HC-600 and HC-1500), K173485. 9. Description of Device The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 are designed for…
STERIS Corporation2018—
*K173490Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)
Summary page 26
…21 CFR 880.6880 Product Code: FLE, PEC 14. Predicate Device AMSCO Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000), K173490. 15. Description of Device The Amsco Evolution Medium Steam Sterilizer models HC-800 and HC-1000 are designed for…
STERIS Corporation2018—

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 19 years and passes through 1 company; a new generation was cleared every 2.7 years on median.
  • 4 of the 8 ancestors have a recall of any class.

How does its category compare?

All FLE devices

FLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · FLE

4in 2025

2007: 52008: 12009: 82010: 22011: 52012: 52013: 52014: 22015: 32016: 12017: 32018: 82019: 52020: 22021: 52022: 102023: 72024: 22025: 42026 (partial year): 3
2007high 10 (2022) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FLE

184in 2025

2007: 67 days median2009: 109 days median2011: 141 days median2012: 111 days median2013: 241 days median2015: 302 days median2017: 233 days median2018: 146 days median2019: 192 days median2021: 147 days median2022: 133 days median2023: 88 days median2025: 184 days median2026 (partial year): 85 days median
2007high 302 (2015) · low 67 (2007)2026

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

Recalls per year · FLE

1in 2021

2007: 12008: 12011: 12012: 12013: 22015: 12018: 12019: 22021: 12026 (partial year): 1
2007high 2 (2013) · low 0 (2009)2026

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

Adverse event reports per year · FLE

71in 2025

2007: 192008: 212009: 192010: 202011: 632012: 692013: 1122014: 1132015: 682016: 762017: 632018: 902019: 912020: 872021: 812022: 702023: 662024: 642025: 71
2007high 113 (2014) · low 19 (2007)2025

MAUDE reports naming product code FLE, 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
2007567119
20081—121
20098109019
20102—020
20115141163
20125111169
201352412112
20142—0113
20153302168
20161—076
20173233063
20188146190
20195192291
20202—087
20215147181
202210133070
2023788066
20242—064
20254184071
20263851—

What is it indicated for?

The Amsco Evolution Medium Steam Sterilizer Models HC-900 and HC-1200 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations: * Prevacuum — is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. + Steam Flush Pressure-Pulse (SFPP) — is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. The Amsco Evolution…

Read the full statement (189 words)

The Amsco Evolution Medium Steam Sterilizer Models HC-900 and HC-1200 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

* Prevacuum — is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

+ Steam Flush Pressure-Pulse (SFPP) — is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

* Prevacuum — is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

» Steam Flush Pressure-Pulse (SFPP) — is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

The Amsco Evolution Medium Steam Sterilizer Models HC-800 and HC-1000 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

* Prevacuum — is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

* Steam Flush Pressure-Pulse (SFPP) — is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from STERIS Corporation

205 FDA decisions under this applicant name. See the company

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  • 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 FLE

The FLE category page

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  • K252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company) · 2026
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https://510kreport.com/device/K203061 · printed Nov 6, 2026

Cite this page

510(k) Report. “K203061: Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203061

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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