510(k) · Cleared
ClearedAMSCO 600 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 27, 2019 as substantially equivalent to K112403 (STERIS Corporation, 2012) after a 107-day review. Its family tree reaches back 3 generations to 2001. 5 later devices descend from it.
- Decided
- Mar 27, 2019
- Review
- 107 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010865 (2001). 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK010865 Amsco Century Medium Sterilizer, Model CenturySTERIS Corporation · 2001 · Recalled
- 2 generations backK020747 Amsco Century Medium Sterilizer 26 X 26STERIS Corporation · 2002
- 1 generation backK112403 Amsco Chimeron Medium Steam SterlilzerSTERIS Corporation · 2012 · Recalled
- This deviceK183410 AMSCO 600 Steam SterilizerSTERIS Corporation · 2019
- Descendant · cites it directly · 2 of its ownK211500 AMSCO 600 Medium Steam SterilizerSTERIS Corporation · 2021
- Descendant · 2 generations on · 1 of its ownK222543 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature…Steris · 2022
- Descendant · cites it directly · 0 of its ownK213545 Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869Steelco S.P.A. · 2023
- Descendant · 3 generations on · 0 of its ownK222849 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature…Steris · 2022
- Descendant · cites it directly · 0 of its ownK220736 Consolidated HC Steam SterilizerConsolidated Machine Corp. · 2022
Most influential descendants
Showing 5 of 5 · See all- K211500AMSCO 600 Medium Steam SterilizerSTERIS Corporation · 2021 · cites it directly2descendants
- K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris · 2022 · 2 generations on1descendant
- K213545Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869Steelco S.P.A. · 2023 · cites it directly0descendants
- K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris · 2022 · 3 generations on0descendants
- K220736Consolidated HC Steam SterilizerConsolidated Machine Corp. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010865 | Amsco Century Medium Sterilizer, Model Century | STERIS Corporation | 2001 | 1 |
| −2 | K020747 | Amsco Century Medium Sterilizer 26 X 26 | STERIS Corporation | 2002 | — |
| −1 | K112403 | Amsco Chimeron Medium Steam Sterlilzer | STERIS Corporation | 2012 | 1 |
| 0 (this device) | K183410 | AMSCO 600 Steam Sterilizer | STERIS Corporation | 2019 | — |
| +1 | K211500 | AMSCO 600 Medium Steam Sterilizer | STERIS Corporation | 2021 | — |
| +2 | K222543 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System… | Steris | 2022 | — |
| +1 | K213545 | Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 | Steelco S.P.A. | 2023 | — |
| +3 | K222849 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System… | Steris | 2022 | — |
| +1 | K220736 | Consolidated HC Steam Sterilizer | Consolidated Machine Corp. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 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 |
|---|---|---|---|
| * | K112403 | Amsco Chimeron Medium Steam SterlilzerSummary page 6…ssification Name: Sterilizer, Steam Classification Number: 21 CFR 880.6880 Product Code: FLE 2. Predicate Device K112403 AMSCO Chimeron Steam Sterilizer (later renamed AMSCO 400) 3. Description of Device The AMSCO 600 Steam Sterilizer use… | 2012 |
What descends from it? (5)
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 18 years and passes through 1 company; a new generation was cleared every 6.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K211500 (STERIS Corporation, 2021) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K112403.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 600 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles (Table 1):
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/K183410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183410: AMSCO 600 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/K183410
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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