510(k) · Cleared
ClearedAmerican Gold Series Autoclave
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tuttnauer Co., Ltd. · FLE Sterilizer, Steam
Cleared on Jan 11, 1984 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jan 11, 1984
- Review
- 69 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK833837 American Gold Series AutoclaveTuttnauer Co., Ltd. · 1984
- Descendant · cites it directly · 3 of its ownK953938 SterilemaxBarnstead/Thermolyne Corp. · 1997
- Descendant · 2 generations on · 2 of its ownK112811 Saniclave 200Alternative Pioneering Research and Development · 2012
- Descendant · 3 generations on · 0 of its ownK180272 Saniclave 250Revolutionary Science · 2018
- Descendant · 3 generations on · 0 of its ownK122978 Saniclave 102, Model RS-SC-102Alternative Pioneering Research and Development · 2013
- Descendant · cites it directly · 0 of its ownK973550 Tuttnauer Table-Top AutoclaveTuttnauer U.S.A Co, Ltd. · 1997
Most influential descendants
Showing 5 of 5 · See all- K953938SterilemaxBarnstead/Thermolyne Corp. · 1997 · cites it directly3descendants
- K112811Saniclave 200Alternative Pioneering Research and Development · 2012 · 2 generations on2descendants
- K180272Saniclave 250Revolutionary Science · 2018 · 3 generations on0descendants
- K122978Saniclave 102, Model RS-SC-102Alternative Pioneering Research and Development · 2013 · 3 generations on0descendants
- K973550Tuttnauer Table-Top AutoclaveTuttnauer U.S.A Co, Ltd. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K833837 | American Gold Series Autoclave | Tuttnauer Co., Ltd. | 1984 | — |
| +1 | K953938 | Sterilemax | Barnstead/Thermolyne Corp. | 1997 | — |
| +2 | K112811 | Saniclave 200 | Alternative Pioneering Research and Development | 2012 | — |
| +3 | K180272 | Saniclave 250 | Revolutionary Science | 2018 | — |
| +3 | K122978 | Saniclave 102, Model RS-SC-102 | Alternative Pioneering Research and Development | 2013 | — |
| +1 | K973550 | Tuttnauer Table-Top Autoclave | Tuttnauer U.S.A Co, Ltd. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 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, K953938 (Barnstead/Thermolyne Corp., 1997) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K833837 · printed Nov 5, 2026
Cite this page
510(k) Report. “K833837: American Gold Series Autoclave.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K833837
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026