510(k) · Cleared
ClearedBelimed Steam Sterilizer, Model Top 5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sauter AG · FLE Sterilizer, Steam
Cleared on Jun 26, 2002 as substantially equivalent to K964332 (Amsco Intl., Inc., 1998) after a 69-day review. Its family tree reaches back 1 generation to 1998. 4 later devices descend from it.
- Decided
- Jun 26, 2002
- Review
- 69 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K964332 (1998). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK964332 Eagle Century Steam SterilizerAmsco Intl., Inc. · 1998 · Recalled
- This deviceK021223 Belimed Steam Sterilizer, Model Top 5000Sauter AG · 2002
- Descendant · cites it directly · 1 of its ownK170228 Belimed Steam Sterilizer MST-H TOP 5000Belimed AG · 2017
- Descendant · 2 generations on · 0 of its ownK191896 Belimed Steam Sterilizer MST-H TOP 5000Belimed AG · 2019
- Descendant · cites it directly · 0 of its ownK141879 Belimed Steam Sterilizer MST-HSauter AG · 2015
- Descendant · cites it directly · 0 of its ownK072087 Belimed Steam Sterilizer Model Top 5000 Series 24Belimed Sauter AG · 2007
Most influential descendants
Showing 4 of 4 · See all- K170228Belimed Steam Sterilizer MST-H TOP 5000Belimed AG · 2017 · cites it directly1descendant
- K191896Belimed Steam Sterilizer MST-H TOP 5000Belimed AG · 2019 · 2 generations on0descendants
- K141879Belimed Steam Sterilizer MST-HSauter AG · 2015 · 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 |
|---|---|---|---|---|---|
| −1 | K964332 | Eagle Century Steam Sterilizer | Amsco Intl., Inc. | 1998 | 2 |
| 0 (this device) | K021223 | Belimed Steam Sterilizer, Model Top 5000 | Sauter AG | 2002 | — |
| +1 | K170228 | Belimed Steam Sterilizer MST-H TOP 5000 | Belimed AG | 2017 | — |
| +2 | K191896 | Belimed Steam Sterilizer MST-H TOP 5000 | Belimed AG | 2019 | — |
| +1 | K141879 | Belimed Steam Sterilizer MST-H | Sauter AG | 2015 | — |
| +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 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K011086 | FDA’s K011086 is Hardydisk Bacitracin, 10MCG, Model Z927 Our reading of the summary gave K011086, FDA’s number for Hardydisk Bacitracin, 10MCG, Model Z927 (Hardy Diagnostics). Its FDA name has none of the distinctive words the summary uses for the device it names, “Amsco Century Medium Steam Sterilizer”. Kept off the family tree. | 2001 |
| * | K964332 | Eagle Century Steam SterilizerSummary page 1…e Belimed Steam Sterilizer TOP 5000 is substantially equivalent to the predicate devices, the Amsco Century Medium Steam Sterilizer, KO1 10865 and Amsco Steam Sterilizer K964332. The Belimed Steam Sterilizer TOP 5000 is intended for the terminal sterilization of heat and moisture- stable materials in healt… | 1998 |
What descends from it? (4)
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?
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 is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021223 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021223: Belimed Steam Sterilizer, Model Top 5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021223
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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