510(k) · Cleared
ClearedBelimed Steam Sterilizer Top 5000, Series 8, Models: 6-0-12 VS1 and VS2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Belimed Sauter AG · FLE Sterilizer, Steam
Cleared on Sep 23, 2009 as substantially equivalent to K033538 (Sauter AG, 2004) after a 225-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Sep 23, 2009
- Review
- 225 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K033538 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK033538 Belimed Steam Sterilizer Top 5000, Series 4 - 8Sauter AG · 2004
- This deviceK090339 Belimed Steam Sterilizer Top 5000, Series 8, Models: 6-0-12 VS1 and…Belimed Sauter AG · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033538 | Belimed Steam Sterilizer Top 5000, Series 4 - 8 | Sauter AG | 2004 | — |
| 0 (this device) | K090339 | Belimed Steam Sterilizer Top 5000, Series 8, Models: 6-0-12 VS1 and VS2 | Belimed Sauter AG | 2009 | — |
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 |
|---|---|---|---|
| * | K033538 | Belimed Steam Sterilizer Top 5000, Series 4 - 8Summary page 1…er 21 CFR 880.6880 Predicate Device: Steam Sterilizer TOP 5000, Series 8, cleared under 510(k) K033538. Device Description: The Belimed Steam Sterilizer TOP 5000 Series 8 is intended for use in hospital and health care facilities… | 2004 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K033538.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Belimed Steam Sterilizer TOP 5000, Series 8, model 6-0-12 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 8, model 6-0-12, is equipped with the
following factory-programmed Sterilization cycles and values (Tables 1-3).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090339: Belimed Steam Sterilizer Top 5000, Series 8, Models: 6-0-12 VS1 and VS2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090339
Report an extraction error
Are you the manufacturer?
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