510(k) · Cleared
ClearedSaniclave 200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alternative Pioneering Research and Development · FLE Sterilizer, Steam
Cleared on Jan 11, 2012 as substantially equivalent to K953938 (Barnstead/Thermolyne Corp., 1997) after a 106-day review. Its family tree reaches back 2 generations to 1984. 2 later devices descend from it.
- Decided
- Jan 11, 2012
- Review
- 106 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K833837 (1984). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK833837 American Gold Series AutoclaveTuttnauer Co., Ltd. · 1984
- 1 generation backK953938 SterilemaxBarnstead/Thermolyne Corp. · 1997
- This deviceK112811 Saniclave 200Alternative Pioneering Research and Development · 2012
- Descendant · cites it directly · 0 of its ownK180272 Saniclave 250Revolutionary Science · 2018
- Descendant · cites it directly · 0 of its ownK122978 Saniclave 102, Model RS-SC-102Alternative Pioneering Research and Development · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K833837 | American Gold Series Autoclave | Tuttnauer Co., Ltd. | 1984 | — |
| −1 | K953938 | Sterilemax | Barnstead/Thermolyne Corp. | 1997 | — |
| 0 (this device) | K112811 | Saniclave 200 | Alternative Pioneering Research and Development | 2012 | — |
| +1 | K180272 | Saniclave 250 | Revolutionary Science | 2018 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K953938 | SterilemaxSummary page 1…olutionary Science Saniclave 200 (RS-SC-200) is claimed to be substantially equivalent to the FDA cleared B/T (BarnsteadlThermolyne) "Sterilemax" under the 510(k) number K953938. Technical Characteristics, Intended use and cycle parameters are all similar to the predicate device. Intended Use: The Revolut… | 1997 |
What descends from it? (2)
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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 14.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K180272 (Revolutionary Science, 2018) 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. 2012, 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 Revolutionary Science Saniclave 200 is designed to be used in medical and dental clinics, hospitals and other facilities where reusable sterile equipment is used. It is intended to sterilize wrapped and unwrapped heat and moisture stable solid instruments, mated surfaces, knurled and hinged devices (excluding lumened devices and dental hand pieces) that are compatible with saturated steam sterilization at 121 degrees Celsius for 30 minutes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112811: Saniclave 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112811
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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