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 Dec 30, 2008 as substantially equivalent to K010865 (STERIS Corporation, 2001) and 1 other predicate after a 130-day review. Its family tree reaches back 2 generations to 2001. 8 later devices descend from it. It has been recalled 4 times.
- Decided
- Dec 30, 2008
- Review
- 130 days
- Class
- Class II
- Product code
- FLE
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010865 (2001). 8 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK010865 Amsco Century Medium Sterilizer, Model CenturySTERIS Corporation · 2001 · Recalled
- 1 generation backK020747 Amsco Century Medium Sterilizer 26 X 26STERIS Corporation · 2002
- This deviceK082435 Amsco Evolution Medium Steam SterilizerSTERIS Corporation · 2008
- Descendant · cites it directly · 4 of its ownK091136 Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200STERIS Corporation · 2009 · Recalled
- Descendant · cites it directly · 2 of its ownK091731 Amsco Evolution Medium Steam SterilizerSTERIS Corporation · 2009 · Recalled
- Descendant · 2 generations on · 1 of its ownK173481 Amsco Evolution Medium Steam SterilizerSTERIS Corporation · 2018
- Descendant · cites it directly · 1 of its ownK173485 Amsco Evolution Medium Steam SterilizerSTERIS Corporation · 2018
- Descendant · 2 generations on · 1 of its ownK173490 Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)STERIS Corporation · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K091136Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200STERIS Corporation · 2009 · cites it directly4descendants
- K091731Amsco Evolution Medium Steam SterilizerSTERIS Corporation · 2009 · cites it directly2descendants
- K173481Amsco Evolution Medium Steam SterilizerSTERIS Corporation · 2018 · 2 generations on1descendant
- K173485Amsco Evolution Medium Steam SterilizerSTERIS Corporation · 2018 · cites it directly1descendant
- K173490Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)STERIS Corporation · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010865 | Amsco Century Medium Sterilizer, Model Century | STERIS Corporation | 2001 | 1 |
| −1 | K020747 | Amsco Century Medium Sterilizer 26 X 26 | STERIS Corporation | 2002 | — |
| 0 (this device) | K082435 | Amsco Evolution Medium Steam Sterilizer | STERIS Corporation | 2008 | — |
| +1 | K091136 | Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200 | STERIS Corporation | 2009 | 3 |
| +1 | K091731 | Amsco Evolution Medium Steam Sterilizer | STERIS Corporation | 2009 | 1 |
| +2 | K173481 | Amsco Evolution Medium Steam Sterilizer | STERIS Corporation | 2018 | — |
| +1 | K173485 | Amsco Evolution Medium Steam Sterilizer | STERIS Corporation | 2018 | — |
| +2 | K173490 | Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) | STERIS Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2018 | 4 | 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? (2)
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 |
|---|---|---|---|
| * | K010865 | Amsco Century Medium Sterilizer, Model CenturySummary page 2…cation Name: Steam Sterilizer (21 CFR 880.6880, Product Code FLE. 2. Predicate Devices * K010865, Amsco Century Medium Steam Sterilizer, product code [FLE] cleared May 31, 2001. K02074… | 2001 |
| * | K020747 | Amsco Century Medium Sterilizer 26 X 26Summary page 2…redicate Devices * K010865, Amsco Century Medium Steam Sterilizer, product code [FLE] cleared May 31, 2001. K020747 Amsco Century Medium Steam Sterilizer, product code [FLE] cleared May 17, 2002. 3. Description of D… | 2002 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 |
| Dec 26, 2018 | Class II | Z-0824-2019 | Device Design | The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when the loading car is empty, potentially resulting in the loading car unexpectedly sliding forward or falling to one side. |
| Oct 18, 2013 | Class II | Z-0478-2014 | Device Design | The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force. |
| Mar 23, 2012 | Not classified | Z-1522-2012 | Device Design | Through Customer feedback and field service experience, STERIS learned that operators may experience difficulty when inserting or removing equipment from the Evolution sterilizer using the transfer carriage due to the following issues… |
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 6.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K091136 (STERIS Corporation, 2009) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K010865.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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-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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082435 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082435: Amsco Evolution Medium Steam Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082435
Report an extraction error
Are you the manufacturer?
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