510(k) · Cleared
ClearedAmsco Century Medium Sterilizer 26 X 26
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 17, 2002 as substantially equivalent to K010865 (STERIS Corporation, 2001) after a 71-day review. Its family tree reaches back 1 generation to 2001. 17 later devices descend from it.
- Decided
- May 17, 2002
- Review
- 71 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010865 (2001). 17 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK010865 Amsco Century Medium Sterilizer, Model CenturySTERIS Corporation · 2001 · Recalled
- This deviceK020747 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 · cites it directly · 7 of its ownK112403 Amsco Chimeron Medium Steam SterlilzerSTERIS Corporation · 2012 · Recalled
- Descendant · 2 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
- Descendant · 3 generations on · 2 of its ownK211500 AMSCO 600 Medium Steam SterilizerSTERIS Corporation · 2021
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K082435Amsco Evolution Medium Steam SterilizerSTERIS Corporation · 2008 · cites it directly8descendants
- K112403Amsco Chimeron Medium Steam SterlilzerSTERIS Corporation · 2012 · cites it directly7descendants
- K183410AMSCO 600 Steam SterilizerSTERIS Corporation · 2019 · 2 generations on5descendants
- K091136Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200STERIS Corporation · 2009 · 2 generations on4descendants
- K211500AMSCO 600 Medium Steam SterilizerSTERIS Corporation · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010865 | Amsco Century Medium Sterilizer, Model Century | STERIS Corporation | 2001 | 1 |
| 0 (this device) | K020747 | Amsco Century Medium Sterilizer 26 X 26 | STERIS Corporation | 2002 | — |
| +1 | K082435 | Amsco Evolution Medium Steam Sterilizer | STERIS Corporation | 2008 | 4 |
| +1 | K112403 | Amsco Chimeron Medium Steam Sterlilzer | STERIS Corporation | 2012 | 1 |
| +2 | 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 |
| +3 | K211500 | AMSCO 600 Medium Steam Sterilizer | STERIS Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 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), 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 |
|---|---|---|---|
| * | K010865 | Amsco Century Medium Sterilizer, Model CenturySummary page 1…n healtheare facilities. The Amsco Century Medium Steam Sterilizer 26” x 26” is substantially equivalent with the predicate device Amsco Century Medium Steam Sterilizer, K010865, cleared May 31, 2001. The Amsco Century Medijum Prevacuum Steam Sterilizer 26 x 26” is equipped with the following factory-prog… | 2001 |
What descends from it? (17)
See all 172 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 | — |
What is it indicated for?
The Amsco Century Medium Steam Sterilizer 26” x 26” is designed for sterilization of heat and moisture-stabile materials used in heaithcare facilities and is available in two configurations: e Prevacuum — is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. e Steam Flush Pressure-Pulse (SFPP) — is equipped with SFPP, WRAP/SFPP, Prevacuum, Gravity, Leak Test and DART (Bowie-Dick) cycles. The Amsco Century Medium Prevacuum…
Read the full statement (106 words)
The Amsco Century Medium Steam Sterilizer 26” x 26” is designed for sterilization of heat and moisture-stabile materials used in heaithcare facilities and is available in two configurations:
e Prevacuum — is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
e Steam Flush Pressure-Pulse (SFPP) — is equipped with SFPP, WRAP/SFPP, Prevacuum, Gravity, Leak Test and DART (Bowie-Dick) cycles.
The Amsco Century Medium Prevacuum Sterilizer 26™ x 267 is equipped with the following factory-programmed sterilization cycles and cycle values (Table 1-A):
The Amsco Century Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 1-B):
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020747 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020747: Amsco Century Medium Sterilizer 26 X 26.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020747
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