510(k) · Cleared
ClearedSterilemax
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Barnstead/Thermolyne Corp. · FLE Sterilizer, Steam
Cleared on Jan 30, 1997 as substantially equivalent to K833837 (Tuttnauer Co., Ltd., 1984) and 1 other predicate after a 528-day review. Its family tree reaches back 1 generation to 1984. 3 later devices descend from it.
- Decided
- Jan 30, 1997
- Review
- 528 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K833837 (1984). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK833837 American Gold Series AutoclaveTuttnauer Co., Ltd. · 1984
- This deviceK953938 SterilemaxBarnstead/Thermolyne Corp. · 1997
- Descendant · cites it directly · 2 of its ownK112811 Saniclave 200Alternative Pioneering Research and Development · 2012
- Descendant · 2 generations on · 0 of its ownK180272 Saniclave 250Revolutionary Science · 2018
- Descendant · 2 generations on · 0 of its ownK122978 Saniclave 102, Model RS-SC-102Alternative Pioneering Research and Development · 2013
Most influential descendants
Showing 3 of 3 · See all- K112811Saniclave 200Alternative Pioneering Research and Development · 2012 · cites it directly2descendants
- K180272Saniclave 250Revolutionary Science · 2018 · 2 generations on0descendants
- K122978Saniclave 102, Model RS-SC-102Alternative Pioneering Research and Development · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K833837 | American Gold Series Autoclave | Tuttnauer Co., Ltd. | 1984 | — |
| 0 (this device) | K953938 | Sterilemax | Barnstead/Thermolyne Corp. | 1997 | — |
| +1 | K112811 | Saniclave 200 | Alternative Pioneering Research and Development | 2012 | — |
| +2 | K180272 | Saniclave 250 | Revolutionary Science | 2018 | — |
| +2 | K122978 | Saniclave 102, Model RS-SC-102 | Alternative Pioneering Research and Development | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K833837 | American Gold Series AutoclaveSummary page 1…antially equivalent in safety and effectiveness to the following two steam sterilizers currently approved and legally marketed; the Tuttenauer American Gold - 510(k) No. K833837 and the MDT S-8 - 510(k) No. K910777. General Description: The B/T "Sterilemax" is a table top steam sterilizer. As in the case… | 1984 |
| * | K910777 | MDT/Castle Models S-8 Table Top Steam SterilizerSummary page 1…ectiveness to the following two steam sterilizers currently approved and legally marketed; the Tuttenauer American Gold - 510(k) No. K833837 and the MDT S-8 - 510(k) No. K910777. General Description: The B/T "Sterilemax" is a table top steam sterilizer. As in the case of the predicate units, the Sterilem… | 1992 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112811 | Saniclave 200 | 2012 | 2 |
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 "Sterilemax" provides sterilization of standard loads of medical and dental instruments, as do the predicate units.
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/K953938 · printed Nov 5, 2026
Cite this page
510(k) Report. “K953938: Sterilemax.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K953938
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