510(k) · Cleared
Recalled · Class II · 2019Amsco Evolution Medium Steam Sterilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · FLE Sterilizer, Steam
Cleared on Sep 17, 2009 as substantially equivalent to K082435 (STERIS Corporation, 2008) after a 98-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 17, 2009
- Review
- 98 days
- Class
- Class II
- Product code
- FLE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010865 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK010865 Amsco Century Medium Sterilizer, Model CenturySTERIS Corporation · 2001 · Recalled
- 2 generations backK020747 Amsco Century Medium Sterilizer 26 X 26STERIS Corporation · 2002
- 1 generation backK082435 Amsco Evolution Medium Steam SterilizerSTERIS Corporation · 2008 · Recalled
- This deviceK091731 Amsco Evolution Medium Steam SterilizerSTERIS Corporation · 2009
- Descendant · cites it directly · 1 of its ownK173490 Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)STERIS Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK203061 Amsco Evolution Medium Steam Sterilizer (Models HC-900 and…STERIS Corporation · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010865 | Amsco Century Medium Sterilizer, Model Century | STERIS Corporation | 2001 | 1 |
| −2 | K020747 | Amsco Century Medium Sterilizer 26 X 26 | STERIS Corporation | 2002 | — |
| −1 | K082435 | Amsco Evolution Medium Steam Sterilizer | STERIS Corporation | 2008 | 4 |
| 0 (this device) | K091731 | Amsco Evolution Medium Steam Sterilizer | STERIS Corporation | 2009 | — |
| +1 | K173490 | Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) | STERIS Corporation | 2018 | — |
| +2 | K203061 | Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution… | STERIS Corporation | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 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 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 K250168 Life Ultra 25L Tabletop Mono Chamber Steam…score 12.7 · 8 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 |
|---|---|---|---|
| * | K082435 | Amsco Evolution Medium Steam SterilizerSummary page 2…lizer Classification Name: Steam Sterilizer (21 CFR 880.6880) Product Code 80 FLE 2. Predicate Device K082435, Amsco Evolution Medium Steam Sterilizer, product code [FLE] cleared December 30, 2008. 3. Description of Device… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173490 | Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) | 2018 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 22, 2019 | Class II | Z-0586-2020 | Process control | The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result in the transfer carriage and loading car unexpectedly falling forward |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 12 months on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K173490 (STERIS Corporation, 2018) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K082435.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FLE
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLE
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLE
71in 2025
MAUDE reports naming product code FLE, 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 | 5 | 67 | 1 | 19 |
| 2008 | 1 | — | 1 | 21 |
| 2009 | 8 | 109 | 0 | 19 |
| 2010 | 2 | — | 0 | 20 |
| 2011 | 5 | 141 | 1 | 63 |
| 2012 | 5 | 111 | 1 | 69 |
| 2013 | 5 | 241 | 2 | 112 |
| 2014 | 2 | — | 0 | 113 |
| 2015 | 3 | 302 | 1 | 68 |
| 2016 | 1 | — | 0 | 76 |
| 2017 | 3 | 233 | 0 | 63 |
| 2018 | 8 | 146 | 1 | 90 |
| 2019 | 5 | 192 | 2 | 91 |
| 2020 | 2 | — | 0 | 87 |
| 2021 | 5 | 147 | 1 | 81 |
| 2022 | 10 | 133 | 0 | 70 |
| 2023 | 7 | 88 | 0 | 66 |
| 2024 | 2 | — | 0 | 64 |
| 2025 | 4 | 184 | 0 | 71 |
| 2026 | 3 | 85 | 1 | — |
What is it indicated for?
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 as stated in the FDA summary.
https://510kreport.com/device/K091731 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091731: Amsco Evolution Medium Steam Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091731
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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