510(k) · Cleared
ClearedSkyron Integrity 215 Steam Sterilizer Skytron Integrity 215 SG Steam Sterilizer Sakura Steam Sterilizer Assv-AB09 Sakura
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sakura Seiki Co., Ltd. · FLE Sterilizer, Steam
Cleared on May 8, 2012 as substantially equivalent to K030789 (STERIS Corporation, 2003) after a 111-day review. Its family tree reaches back 5 generations to 1982. 2 later devices descend from it.
- Decided
- May 8, 2012
- Review
- 111 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K820783 (1982). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK820783 Castle Microcomputer Sterilizer ControlSybron Corp. · 1982
- 4 generations backK970907 Castle Series 100 Steam Sterilizers (Straightline)Getinge/Castle, Inc. · 1997
- 3 generations backK994314 Castle Series 100HC Steam SterilizersGetinge/Castle, Inc. · 2000
- 2 generations backK012573 Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC…Getinge/Castle, Inc. · 2001
- 1 generation backK030789 Amsco Century Steam SterilizerSTERIS Corporation · 2003
- This deviceK120149 Skyron Integrity 215 Steam Sterilizer Skytron Integrity 215 SG Steam…Sakura Seiki Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK132439 Sakura Steam Sterilizer Assr; -AO12, -A012W, -AO12P,-AO12PW /…Sakura Seiki Co., Ltd. · 2014 · Recalled
- Descendant · cites it directly · 0 of its ownK122774 Sakura Steam Sterilizaer Model Assv-AH06; Sakura Steam Sterilizer…Sakura Seiki Co., Ltd. · 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 |
|---|---|---|---|---|---|
| −5 | K820783 | Castle Microcomputer Sterilizer Control | Sybron Corp. | 1982 | — |
| −4 | K970907 | Castle Series 100 Steam Sterilizers (Straightline) | Getinge/Castle, Inc. | 1997 | — |
| −3 | K994314 | Castle Series 100HC Steam Sterilizers | Getinge/Castle, Inc. | 2000 | — |
| −2 | K012573 | Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and… | Getinge/Castle, Inc. | 2001 | — |
| −1 | K030789 | Amsco Century Steam Sterilizer | STERIS Corporation | 2003 | — |
| 0 (this device) | K120149 | Skyron Integrity 215 Steam Sterilizer Skytron Integrity 215 SG Steam… | Sakura Seiki Co., Ltd. | 2012 | — |
| +1 | K132439 | Sakura Steam Sterilizer Assr; -AO12, -A012W, -AO12P,-AO12PW / Skytron… | Sakura Seiki Co., Ltd. | 2014 | 1 |
| +1 | K122774 | Sakura Steam Sterilizaer Model Assv-AH06; Sakura Steam Sterilizer Model… | Sakura Seiki Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K030789 | Amsco Century Steam SterilizerSummary page 1…Usual Name: Common name; Steam Sterilizer Classification name: Sterilizer, Steam Predicate Device Information: Steris Amsco Century Gravity and Prevacuum Sterilizers K030789 . Description: The SKYTRON integrity 215 Steam Sterilizer, SKYTRON Integrity 215 SG Steam Sterilizer, Sakura Steam Stenlizer AS… | 2003 |
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 30 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K132439 (Sakura Seiki Co., Ltd., 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K030789.
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?
Sakura Steam Sterilizer ASSV-AB-09 / Skytron Integrity 215 Steam Sterilizer, Sakura Steam Sterilizer ASSV-ABO9E / Skytron Integrity 215 SG Steam Sterilizer are designed and optimized for use in health care facilities. Sakura Steam Sterilizer ASSV-AB-08 / Skytron Integrity 215 Steam Sterilizer, Sakura Steam Sterilizer ASSV-ABOSE / Skytron Integrity 215 SG Steam Sterilizer incorporate high-pressure steam to sterilize non-porous and porous, heat and…
Read the full statement (128 words)
Sakura Steam Sterilizer ASSV-AB-09 / Skytron Integrity 215 Steam Sterilizer, Sakura Steam Sterilizer ASSV-ABO9E / Skytron Integrity 215 SG Steam Sterilizer are designed and optimized for use in health care facilities. Sakura Steam Sterilizer ASSV-AB-08 / Skytron Integrity 215 Steam Sterilizer, Sakura Steam Sterilizer ASSV-ABOSE / Skytron Integrity 215 SG Steam Sterilizer incorporate high-pressure steam to sterilize non-porous and porous, heat and moisture-stable items and materials used in the health care facilities. Sakura Steam Sterilizer ASSV-AB-09 / Skytron Integrity 215 Steam Sterilizer, Sakura Steam Sterilizer ASSV-ABO9E / Skytron Integrity 215 SG Steam Sterilize are available in the following configuration.
Note: Sakura Steam Sterilizer ASSV-AB09E / SKYTRON Integrity 215 SG Steam Sterilizer equip the integrated steam generator.
21.5" x 21.5" x 38" chamber size, Single Door Prevacuum and Gravity.
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/K120149 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120149: Skyron Integrity 215 Steam Sterilizer Skytron Integrity 215 SG Steam Sterilizer Sakura Steam Sterilizer Assv-AB09 Sakura.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120149
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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