510(k) · Cleared
ClearedAMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · FLE Sterilizer, Steam
Cleared on Oct 28, 2021 as substantially equivalent to K111223 (STERIS Corporation, 2011) and 2 other predicates after an 85-day review. Its family tree reaches back 6 generations to 1982.
- Decided
- Oct 28, 2021
- Review
- 85 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K820783 (1982). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK820783 Castle Microcomputer Sterilizer ControlSybron Corp. · 1982
- 5 generations backK970907 Castle Series 100 Steam Sterilizers (Straightline)Getinge/Castle, Inc. · 1997
- 4 generations backK994314 Castle Series 100HC Steam SterilizersGetinge/Castle, Inc. · 2000
- 3 generations backK012573 Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC…Getinge/Castle, Inc. · 2001
- 2 generations backK030789 Amsco Century Steam SterilizerSTERIS Corporation · 2003
- 1 generation backK111223 Amsco Chimeron Small Steam SterilizerSTERIS Corporation · 2011 · Recalled
- This deviceK212424 AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam SterilizersSTERIS Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K820783 | Castle Microcomputer Sterilizer Control | Sybron Corp. | 1982 | — |
| −5 | K970907 | Castle Series 100 Steam Sterilizers (Straightline) | Getinge/Castle, Inc. | 1997 | — |
| −4 | K994314 | Castle Series 100HC Steam Sterilizers | Getinge/Castle, Inc. | 2000 | — |
| −3 | K012573 | Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and… | Getinge/Castle, Inc. | 2001 | — |
| −2 | K030789 | Amsco Century Steam Sterilizer | STERIS Corporation | 2003 | — |
| −1 | K111223 | Amsco Chimeron Small Steam Sterilizer | STERIS Corporation | 2011 | 3 |
| 0 (this device) | 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 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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? (3)
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 |
|---|---|---|---|
| * | K111223 | Amsco Chimeron Small Steam SterilizerSummary page 12…lassification Name: Sterilizer, Steam Classification Number: 21 CFR 880.6880 Product Code: FLE 2. Predicate Devices K111223 - AMSCO Chimeron Small Steam Sterilizer (renamed AMSCO 400 before commercialization) The proposed device is ide… | 2011 |
| * | K112403 | Amsco Chimeron Medium Steam SterlilzerSummary page 18…assification Name: Sterilizer, Steam Classification Number: 21 CFR 880.6880 Product Code: FLE 7. Predicate Devices K112403 - Chimeron Medium 26” x 26” Steam Sterilizer (renamed AMSCO 400 before commercialization) The proposed device is… | 2012 |
| * | K112055 | Amsco Chimeron Medium Steam SterilizerSummary page 22…ification Name: Sterilizer, Steam Classification Number: 21 CFR 880.6880 Product Code: FLE 12. Predicate Devices K112055 – AMSCO 400 Medium Steam Sterilizer (renamed AMSCO 400 before commercialization) The proposed device is ident… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 39 years and passes through 3 companies; a new generation was cleared every 8.5 years on median.
- 5 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K111223.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 400 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…
Read the full statement (179 words)
The Amsco 400 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.
The AMSCO 400 Medium Steam Sterilizers (Models 39SL and 39CSL) are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in the following configuration:
• Prevacuum – equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The AMSCO 400 Medium Steam Sterilizers (Models 36H, 48H, 60H, 36SL, 48SL, 60SL, 36CH, 48CH, 60CH, 36CSL, 48CSL and 60CSL) are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in the following configuration:
• Prevacuum – equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212424: AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212424
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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