510(k) · Cleared
ClearedBravo Autoclave, Models 17, 17V and 21V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scican, Ltd. · FLE Sterilizer, Steam
Cleared on May 15, 2009 as substantially equivalent to K050263 (M.O. Com S.R.L., 2006) after a 101-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- May 15, 2009
- Review
- 101 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K936181 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK936181 Midmark M-11 Ultraclave Steam SterilizerMidmark Corp. · 1994 · Recalled
- 3 generations backK990189 Modification of: Midmark M-11 Ultraclave Steam SterilizerMidmark Corp. · 1999
- 2 generations backK023348 Midmark M9 Ultraclave Steam SterilizerMidmark Corp. · 2003
- 1 generation backK050263 Millennium Series, Including Millennium B, B+, B2 and BUM.O. Com S.R.L. · 2006
- This deviceK090265 Bravo Autoclave, Models 17, 17V and 21VScican, Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K936181 | Midmark M-11 Ultraclave Steam Sterilizer | Midmark Corp. | 1994 | 1 |
| −3 | K990189 | Modification of: Midmark M-11 Ultraclave Steam Sterilizer | Midmark Corp. | 1999 | — |
| −2 | K023348 | Midmark M9 Ultraclave Steam Sterilizer | Midmark Corp. | 2003 | — |
| −1 | K050263 | Millennium Series, Including Millennium B, B+, B2 and BU | M.O. Com S.R.L. | 2006 | — |
| 0 (this device) | K090265 | Bravo Autoclave, Models 17, 17V and 21V | Scican, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 |
|---|---|---|---|
| * | K050263 | Millennium Series, Including Millennium B, B+, B2 and BUSummary page 1…BRAVO series Autoclaves (17, 17V, 21V) Predicate Device: MO.C.OM. Millennium series Autoclaves 510(k) K050263 Description of Device: to proc… | 2006 |
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 15 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 2 other devices also cite its predicate K050263.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 BRAVO series of Autoclaves are table-top vacuum autoclaves that are intended to be used in medical and dental practices, hospitals, clinics and other associated facilities to sterilize re-usable medical and dental instruments (including dental handpieces) and medical materials that are heat and moisture resistant and compatible with the steam sterilization process.
Typical users of this system are trained professionals including, but not limited to, dentists, nurses, doctors, infection control and re-processing personnel.
The BRAVO series of Autoclaves are not intended nor recommended for the sterilization of fluids, liquids, or pharmaceutical products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090265: Bravo Autoclave, Models 17, 17V and 21V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090265
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