510(k) · Cleared
ClearedAmsco Century 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 Mar 26, 2003 as substantially equivalent to K964332 (Amsco Intl., Inc., 1998) and 1 other predicate after a 14-day review. Its family tree reaches back 4 generations to 1982. 8 later devices descend from it.
- Decided
- Mar 26, 2003
- Review
- 14 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K820783 (1982). 5 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK820783 Castle Microcomputer Sterilizer ControlSybron Corp. · 1982
- 3 generations backK970907 Castle Series 100 Steam Sterilizers (Straightline)Getinge/Castle, Inc. · 1997
- 2 generations backK994314 Castle Series 100HC Steam SterilizersGetinge/Castle, Inc. · 2000
- 1 generation backK012573 Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC…Getinge/Castle, Inc. · 2001
- This deviceK030789 Amsco Century Steam SterilizerSTERIS Corporation · 2003
- Descendant · cites it directly · 3 of its ownK111223 Amsco Chimeron Small Steam SterilizerSTERIS Corporation · 2011 · Recalled
- Descendant · cites it directly · 2 of its ownK120149 Skyron Integrity 215 Steam Sterilizer Skytron Integrity 215 SG Steam…Sakura Seiki Co., Ltd. · 2012
- Descendant · 2 generations on · 1 of its ownK221474 PRIMUS Healthcare Sterilizer (Model PSS11-HC)Primus Sterilizer Company, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK233132 PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)Primus Sterilizer Company, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK212424 AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam SterilizersSTERIS Corporation · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K111223Amsco Chimeron Small Steam SterilizerSTERIS Corporation · 2011 · cites it directly3descendants
- K120149Skyron Integrity 215 Steam Sterilizer Skytron Integrity 215 SG Steam Sterilizer Sakura…Sakura Seiki Co., Ltd. · 2012 · cites it directly2descendants
- K221474PRIMUS Healthcare Sterilizer (Model PSS11-HC)Primus Sterilizer Company, LLC · 2023 · 2 generations on1descendant
- K233132PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)Primus Sterilizer Company, LLC · 2023 · 3 generations on0descendants
- K212424AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam SterilizersSTERIS Corporation · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K820783 | Castle Microcomputer Sterilizer Control | Sybron Corp. | 1982 | — |
| −3 | K970907 | Castle Series 100 Steam Sterilizers (Straightline) | Getinge/Castle, Inc. | 1997 | — |
| −2 | K994314 | Castle Series 100HC Steam Sterilizers | Getinge/Castle, Inc. | 2000 | — |
| −1 | K012573 | Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and… | Getinge/Castle, Inc. | 2001 | — |
| 0 (this device) | K030789 | Amsco Century Steam Sterilizer | STERIS Corporation | 2003 | — |
| +1 | K111223 | Amsco Chimeron Small Steam Sterilizer | STERIS Corporation | 2011 | 3 |
| +1 | K120149 | Skyron Integrity 215 Steam Sterilizer Skytron Integrity 215 SG Steam… | Sakura Seiki Co., Ltd. | 2012 | — |
| +2 | K221474 | PRIMUS Healthcare Sterilizer (Model PSS11-HC) | Primus Sterilizer Company, LLC | 2023 | — |
| +3 | K233132 | PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) | Primus Sterilizer Company, LLC | 2023 | — |
| +2 | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K964332 | Eagle Century Steam SterilizerSummary page 1…stabile materials used in healthcare facilities. The Amsco Century Steam Sterilizer is substantially equivalent with the predicate device Eagle Century Steam Sterilizer, K964332, cleared June 1,1998 and also substantially equivalent to Castle 400HC/500HC Series Steam Sterilizer, K012573, cleared September… | 1998 |
| * | K012573 | Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and 533HCSummary page 1…t with the predicate device Eagle Century Steam Sterilizer, K964332, cleared June 1,1998 and also substantially equivalent to Castle 400HC/500HC Series Steam Sterilizer, K012573, cleared September 5,2001 for the 135°C (275°F) for 3 minutes prevac cycle claim. The Amsco Century Prevacuum Steam Sterilizer (… | 2001 |
What descends from it? (8)
3 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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K111223 (STERIS Corporation, 2011) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K964332.
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 Am~coCentury Steam Sterilizer is designed for efficient steriltzation of non-porous and porous, heat and moisture-stabile materials used in healthcare facilities. The Amsco Century Steam Sterilizer is available in the following configurations: 16” x 16” x 26” Single Door Gravity* 16” x 16” x 26” Single Door Prevacuum 16” x 16” x 26” Double Door Gravity 16” x 16” x 26” Double Door Prevacuum 20” x 20” x 38” Single Door Gravity 20” x 20” x 38” Single…
Read the full statement (342 words)
The Am~coCentury Steam Sterilizer is designed for efficient steriltzation of non-porous and porous, heat and moisture-stabile materials used in healthcare facilities. The Amsco Century Steam Sterilizer is available in the following configurations:
16” x 16” x 26” Single Door Gravity* 16” x 16” x 26” Single Door Prevacuum
16” x 16” x 26” Double Door Gravity 16” x 16” x 26” Double Door Prevacuum
20” x 20” x 38” Single Door Gravity 20” x 20” x 38” Single Door Prevacuum
20” x 20’’ x 38” Double Door Gravity 20” x 20” x 38” Double Door Prevacuum
*Note: No changes are being made to the gravity sterilizers program.
The Amsco Century Steam Sterilizer is equipped with the following factory-programmed set sterilization cyde values:
Cycle — Recommended Loads — Stetilize Temp — Sterilize Time — Dry Time
Flash — Unwrapped instrument tray with a single instrument — 270°F (132°C) — 3 minutes — 1 minute
Flash — Unwrapped instrument tray with multiple non-porous instruments, maximum weight 17 pounds per tray. — 270°F (1 32OC) — 10 minutes — 1 minute
Express — Single wrapped instrument tray with a single instrument. Non-porous goods only. — 270°F (132°C) — 4 minutes — 3 minutes
Prevac — Up to two double wrapped instrument trays, maximum weight 17 pounds per tray. Up to six fabric packs. — 270°F (132°C) — 4 minutes — 20 minutes’
Prevac — Up to two double wrapped instrument trays, maximum weight 17 pounds per tray. — 275°F (135°C) — 3 minutes — 16 minutes
Cycle — Recommended Loads — Sterilize Temp — Sterilize Time — Dry Time
Flash — Unwrapped instrument tray with a single instrument — 270°F (132°C) — 3 minutes
Flash — Unwrapped instrument tray with multiple non-porous instruments, maximum weight 17 pounds per tray. — 270°F (132OC) — 10 minutes
Gravity — Up to two double wrapped instrument trays, maximum weight 17 pounds per tray — 270°F (132°C) — 15 minutes
Gravity — Fabric Packs u,p-b5 ; xr r d - ~ f /&b — 250°F (121°C) — 30 minutes2
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030789 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030789: Amsco Century 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/K030789
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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