510(k) · Cleared
Recalled · Class II · 2015Amsco Chimeron Small 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 20, 2011 as substantially equivalent to K030789 (STERIS Corporation, 2003) after a 141-day review. Its family tree reaches back 5 generations to 1982. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 20, 2011
- Review
- 141 days
- Class
- Class II
- Product code
- FLE
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 5 generations to K820783 (1982). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK820783 Castle Microcomputer Sterilizer ControlSybron Corp. · 1982
- 4 generations backK970907 Castle Series 100 Steam Sterilizers (Straightline)Getinge/Castle, Inc. · 1997
- 3 generations backK994314 Castle Series 100HC Steam SterilizersGetinge/Castle, Inc. · 2000
- 2 generations backK012573 Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC…Getinge/Castle, Inc. · 2001
- 1 generation backK030789 Amsco Century Steam SterilizerSTERIS Corporation · 2003
- This deviceK111223 Amsco Chimeron Small Steam SterilizerSTERIS Corporation · 2011
- Descendant · cites it directly · 1 of its ownK221474 PRIMUS Healthcare Sterilizer (Model PSS11-HC)Primus Sterilizer Company, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK233132 PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)Primus Sterilizer Company, LLC · 2023
- Descendant · cites it directly · 0 of its ownK212424 AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam SterilizersSTERIS Corporation · 2021
Most influential descendants
Showing 3 of 3 · See all- K221474PRIMUS Healthcare Sterilizer (Model PSS11-HC)Primus Sterilizer Company, LLC · 2023 · cites it directly1descendant
- K233132PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)Primus Sterilizer Company, LLC · 2023 · 2 generations on0descendants
- K212424AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam SterilizersSTERIS Corporation · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K820783 | Castle Microcomputer Sterilizer Control | Sybron Corp. | 1982 | — |
| −4 | K970907 | Castle Series 100 Steam Sterilizers (Straightline) | Getinge/Castle, Inc. | 1997 | — |
| −3 | K994314 | Castle Series 100HC Steam Sterilizers | Getinge/Castle, Inc. | 2000 | — |
| −2 | K012573 | Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and… | Getinge/Castle, Inc. | 2001 | — |
| −1 | K030789 | Amsco Century Steam Sterilizer | STERIS Corporation | 2003 | — |
| 0 (this device) | K111223 | Amsco Chimeron Small Steam Sterilizer | STERIS Corporation | 2011 | — |
| +1 | K221474 | PRIMUS Healthcare Sterilizer (Model PSS11-HC) | Primus Sterilizer Company, LLC | 2023 | — |
| +2 | K233132 | PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) | Primus Sterilizer Company, LLC | 2023 | — |
| +1 | K212424 | AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers | STERIS Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K030789 | Amsco Century Steam SterilizerSummary page 1…16C, 16CS, 168, 20, 20C, 20CS, and 20S Common/Usual Name: Steam Sterilizer Classification Name: Steam Sterilizer (21 CFR 880.6880) Product Code FLE Predicate Device K030789, Amsco Century Small Steam Sterilizer, product code [FLE] cleared March 26", 2003. Description of Device The Amsco Chimeron Sma… | 2003 |
What descends from it? (3)
2 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 |
|---|---|---|---|---|
| Sep 3, 2015 | Class III | Z-0210-2016 | Software design | In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator to open and close the sterilizer door. |
| Feb 19, 2015 | Class II | Z-1561-2015 | Software design (manufacturing process) | STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincide with a processing cycle. This may result in a… |
| Feb 12, 2013 | Class II | Z-0915-2013 | Software design | The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during operation. When this alarm occurs, the sterilizer locks up and cannot be… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K221474 (Primus Sterilizer Company, LLC, 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K030789.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Chimeron Small Steam Sterilizer models 16, 16C, 16CS, 16S, 20, 20C, 20CS, and 20S are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations
Prevacuum (Models 16, 16C and 20, 20C) — are equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
Steam Flush Pressure-Pulse (SFPP) (Models 16CS, 16S and 20CS, 20S) — are 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.
https://510kreport.com/device/K111223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111223: Amsco Chimeron Small Steam Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111223
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