510(k) · Cleared
Recalled · 2007Amsco Century Medium Sterilizer, Model Century
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · FLE Sterilizer, Steam
Cleared on May 31, 2001 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it. It has been recalled once.
- Decided
- May 31, 2001
- Review
- 70 days
- Class
- Class II
- Product code
- FLE
- Recalls
- 1
- Predicates
- 0
19 later devices descend from it, 3 citing it directly.
- This deviceK010865 Amsco Century Medium Sterilizer, Model CenturySTERIS Corporation · 2001
- Descendant · cites it directly · 17 of its ownK020747 Amsco Century Medium Sterilizer 26 X 26STERIS Corporation · 2002
- Descendant · cites it directly · 8 of its ownK082435 Amsco Evolution Medium Steam SterilizerSTERIS Corporation · 2008 · Recalled
- Descendant · 2 generations on · 7 of its ownK112403 Amsco Chimeron Medium Steam SterlilzerSTERIS Corporation · 2012 · Recalled
- Descendant · 3 generations on · 5 of its ownK183410 AMSCO 600 Steam SterilizerSTERIS Corporation · 2019
- Descendant · 2 generations on · 4 of its ownK091136 Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200STERIS Corporation · 2009 · Recalled
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K020747Amsco Century Medium Sterilizer 26 X 26STERIS Corporation · 2002 · cites it directly17descendants
- K082435Amsco Evolution Medium Steam SterilizerSTERIS Corporation · 2008 · cites it directly8descendants
- K112403Amsco Chimeron Medium Steam SterlilzerSTERIS Corporation · 2012 · 2 generations on7descendants
- K183410AMSCO 600 Steam SterilizerSTERIS Corporation · 2019 · 3 generations on5descendants
- K091136Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200STERIS Corporation · 2009 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010865 | Amsco Century Medium Sterilizer, Model Century | STERIS Corporation | 2001 | — |
| +1 | K020747 | Amsco Century Medium Sterilizer 26 X 26 | STERIS Corporation | 2002 | — |
| +1 | K082435 | Amsco Evolution Medium Steam Sterilizer | STERIS Corporation | 2008 | 4 |
| +2 | K112403 | Amsco Chimeron Medium Steam Sterlilzer | STERIS Corporation | 2012 | 1 |
| +3 | K183410 | AMSCO 600 Steam Sterilizer | STERIS Corporation | 2019 | — |
| +2 | K091136 | Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200 | STERIS Corporation | 2009 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (19)
See all 193 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 |
|---|---|---|---|---|
| Mar 22, 2007 | Not classified | Z-1193-2007 | Employee error | The cables inside the pump conduit box may be exposed (not covered with wire nut and/or electrical tape) that could cause a potential electrical shock hazard. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K020747 (STERIS Corporation, 2002) has gone furthest, with 17 descendants of its own.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K010865 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010865: Amsco Century Medium Sterilizer, Model Century.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010865
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026