510(k) · Cleared
ClearedBelimed Steam Sterilizer Top 5000, Series 4 - 8
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sauter AG · FLE Sterilizer, Steam
Cleared on Feb 2, 2004 after an 84-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Feb 2, 2004
- Review
- 84 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK033538 Belimed Steam Sterilizer Top 5000, Series 4 - 8Sauter AG · 2004
- Descendant · cites it directly · 0 of its ownK103841 Belimed Steam Sterilizer MST-VSauter AG · 2011
- Descendant · cites it directly · 0 of its ownK090339 Belimed Steam Sterilizer Top 5000, Series 8, Models: 6-0-12 VS1 and…Belimed Sauter AG · 2009
- Descendant · cites it directly · 0 of its ownK072087 Belimed Steam Sterilizer Model Top 5000 Series 24Belimed Sauter AG · 2007
Most influential descendants
Showing 3 of 3 · See all- K103841Belimed Steam Sterilizer MST-VSauter AG · 2011 · cites it directly0descendants
- K090339Belimed Steam Sterilizer Top 5000, Series 8, Models: 6-0-12 VS1 and VS2Belimed Sauter AG · 2009 · cites it directly0descendants
- K072087Belimed Steam Sterilizer Model Top 5000 Series 24Belimed Sauter AG · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033538 | Belimed Steam Sterilizer Top 5000, Series 4 - 8 | Sauter AG | 2004 | — |
| +1 | K103841 | Belimed Steam Sterilizer MST-V | Sauter AG | 2011 | — |
| +1 | K090339 | Belimed Steam Sterilizer Top 5000, Series 8, Models: 6-0-12 VS1 and VS2 | Belimed Sauter AG | 2009 | — |
| +1 | K072087 | Belimed Steam Sterilizer Model Top 5000 Series 24 | Belimed Sauter AG | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | — | Belimed Steam Sterilizer TOP 5000 Series 9 -18 Named without a submission number |
What descends from it? (3)
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?
- Of its descendants, K103841 (Sauter AG, 2011) has gone furthest, with 0 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 Belimed Steam Sterilizer TOP 5000, series 4-8, is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities.
The Belimed Steam Sterilizer TOP 5000 Series 4 - 8 is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033538: Belimed Steam Sterilizer Top 5000, Series 4 - 8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033538
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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