510(k) · Cleared
Recalled · Class II · 2019Eagle Century Steam Sterilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amsco Intl., Inc. · FLE Sterilizer, Steam
Cleared on Jun 1, 1998 after a 579-day review. The FDA summary names no predicate by number. 14 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 1, 1998
- Review
- 579 days
- Class
- Class II
- Product code
- FLE
- Recalls
- 2
- Predicates
- 0
14 later devices descend from it, 2 citing it directly.
- This deviceK964332 Eagle Century Steam SterilizerAmsco Intl., Inc. · 1998
- Descendant · cites it directly · 8 of its ownK030789 Amsco Century Steam SterilizerSTERIS Corporation · 2003
- Descendant · cites it directly · 4 of its ownK021223 Belimed Steam Sterilizer, Model Top 5000Sauter AG · 2002
- Descendant · 2 generations on · 3 of its ownK111223 Amsco Chimeron Small Steam SterilizerSTERIS Corporation · 2011 · Recalled
- Descendant · 2 generations on · 2 of its ownK120149 Skyron Integrity 215 Steam Sterilizer Skytron Integrity 215 SG Steam…Sakura Seiki Co., Ltd. · 2012
- Descendant · 3 generations on · 1 of its ownK221474 PRIMUS Healthcare Sterilizer (Model PSS11-HC)Primus Sterilizer Company, LLC · 2023
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K030789Amsco Century Steam SterilizerSTERIS Corporation · 2003 · cites it directly8descendants
- K021223Belimed Steam Sterilizer, Model Top 5000Sauter AG · 2002 · cites it directly4descendants
- K111223Amsco Chimeron Small Steam SterilizerSTERIS Corporation · 2011 · 2 generations on3descendants
- K120149Skyron Integrity 215 Steam Sterilizer Skytron Integrity 215 SG Steam Sterilizer Sakura…Sakura Seiki Co., Ltd. · 2012 · 2 generations on2descendants
- K221474PRIMUS Healthcare Sterilizer (Model PSS11-HC)Primus Sterilizer Company, LLC · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964332 | Eagle Century Steam Sterilizer | Amsco Intl., Inc. | 1998 | — |
| +1 | K030789 | Amsco Century Steam Sterilizer | STERIS Corporation | 2003 | — |
| +1 | K021223 | Belimed Steam Sterilizer, Model Top 5000 | Sauter AG | 2002 | — |
| +2 | K111223 | Amsco Chimeron Small Steam Sterilizer | STERIS Corporation | 2011 | 3 |
| +2 | K120149 | Skyron Integrity 215 Steam Sterilizer Skytron Integrity 215 SG Steam… | Sakura Seiki Co., Ltd. | 2012 | — |
| +3 | K221474 | PRIMUS Healthcare Sterilizer (Model PSS11-HC) | Primus Sterilizer Company, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 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?
The FDA summary names no predicate by number.
What descends from it? (14)
See all 142 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 |
|---|---|---|---|---|
| Oct 22, 2019 | Class II | Z-0604-2020 | Packaging | Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers. |
| Mar 6, 2008 | Not classified | Z-2350-2008 | Employee error | The firm discovered that some Eagle 3000 units may have a door post pin missing which could cause incomplete or no engagement of the radial arms into the lock rails of the door. The sterilizer is designed with switches that prevent cycle… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K030789 (STERIS Corporation, 2003) has gone furthest, with 8 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 | — |
What is it indicated for?
The STERIS Eagle Century Steam Sterilizer is designed for efficient, sterilization of non-porous and porous, heat and moisture-stabile materials used in healthcare facilities. The Eagle 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"…
Read the full statement (335 words)
The STERIS Eagle Century Steam Sterilizer is designed for efficient, sterilization of non-porous and porous, heat and moisture-stabile materials used in healthcare facilities. The Eagle 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
The Eagle Century Steam Sterilizer is equipped with the following factory-programmed set sterilization cycles and cycle values:
Prevacuum Configuration
CYCLES | RECOMMENDED LOADS | STERILIZE 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 non-porous multiple instruments, maximum weight 17lbs | 270°F (132°C) | 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 17lbs. Up to six fabric packs. | 270°F (132°C) | 4 minutes | 20 minutes'
'Five minute Dry Time can be used for processing a single fabric pack.
GRAVITY CONFIGURATION
CYCLES | RECOMMENDED LOADS | STERILIZE 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 non-porous multiple instruments, maximum weight 17lbs | 270°F (132°C) | 10 minutes | 1 minute
GRAVITY | Up to two double wrapped instrument trays, maximum weight 17lbs | 270°F (132°C) | 15 minutes | 30 minutes
GRAVITY | Fabric Packs | 250°F (121°C) | 30 minutes’ | 15 minutes
A 270°F (132°C) cycle adjusted to 25 minute Sterilize Time can be used for processing fabric packs.
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/K964332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964332: Eagle 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/K964332
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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