510(k) · Cleared
ClearedSaniclave 250
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Revolutionary Science · FLE Sterilizer, Steam
Cleared on Jul 26, 2018 as substantially equivalent to K112811 (Alternative Pioneering Research and Development, 2012) after a 176-day review. Its family tree reaches back 3 generations to 1984.
- Decided
- Jul 26, 2018
- Review
- 176 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K833837 (1984). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK833837 American Gold Series AutoclaveTuttnauer Co., Ltd. · 1984
- 2 generations backK953938 SterilemaxBarnstead/Thermolyne Corp. · 1997
- 1 generation backK112811 Saniclave 200Alternative Pioneering Research and Development · 2012
- This deviceK180272 Saniclave 250Revolutionary Science · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K833837 | American Gold Series Autoclave | Tuttnauer Co., Ltd. | 1984 | — |
| −2 | K953938 | Sterilemax | Barnstead/Thermolyne Corp. | 1997 | — |
| −1 | K112811 | Saniclave 200 | Alternative Pioneering Research and Development | 2012 | — |
| 0 (this device) | K180272 | Saniclave 250 | Revolutionary Science | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 |
|---|---|---|---|
| * | K112811 | Saniclave 200Summary page 4…Predicate Device: The Revolutionary Science Saniclave 250 (RS-SC-250) is claimed to be substantially equivalent to the FDA cleared Saniclave 200 under the 510(k) number K112811. Technical Characteristics, Intended Use, and cycle parameters are all similar to the predicate device. Intended Use: The Revo… | 2012 |
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?
- The line of descent spans 34 years and passes through 4 companies; a new generation was cleared every 13.1 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K112811.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 250 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, hinged devices, including lumened devices and trocars (lumens greater than 3mm inner diameter and less than 70mm in length, excluding dental handpieces) that are compatible…
Read the full statement (232 words)
The Revolutionary Science Saniclave 250 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, hinged devices, including lumened devices and trocars (lumens greater than 3mm inner diameter and less than 70mm in length, excluding dental handpieces) that are compatible with saturated steam sterilization at 121 degrees Celsius for 30 minutes.
The Saniclave 250 has 3 factory-programmed cycles:
Cycle Sterilization Temperature | Sterilize Time | Dry Time | Recommended Load
Gravity, 121°C, small load, wrapped* | 30 minutes | 30 minutes | 1 tray, wrapped* instruments, maximum weight 4.5 Ibs; Heat and moisture stable solid instruments, mated surfaces, knurled, hinged devices, including lumened devices and trocars
Gravity, 121°C, small load, unwrapped* | 30 minutes | N/A | 1 tray, unwrapped* instruments, maximum weight 4.5 Ibs; Heat and moisture stable solid instruments, mated surfaces, knurled, hinged devices, including lumened devices and trocars
Gravity, 121°C, large load, unwrapped* | 30 minutes | N/A | 3 trays, unwrapped* loaded evenly, maximum weight 8.0 Ibs; Heat and moisture stable solid instruments, lumened devices and trocars only
*4 wrapped load is wrapped or pouched in autoclave packaging that is FDA cleared for 30 min at 121°C. An unwrapped load is not wrapped or pouched and is intended for immediate use.
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/K180272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180272: Saniclave 250.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180272
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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