510(k) · Cleared
Recalled · Class II · 2019Sakura Steam Sterilizer Assr; -AO12, -A012W, -AO12P,-AO12PW / Skytron Integrity 270;Steam Sterilizer,VP Steam Sterilizer
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 Jan 6, 2014 as substantially equivalent to K120149 (Sakura Seiki Co., Ltd., 2012) after a 154-day review. Its family tree reaches back 6 generations to 1982. It has been recalled once.
- Decided
- Jan 6, 2014
- Review
- 154 days
- Class
- Class II
- Product code
- FLE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K820783 (1982). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK820783 Castle Microcomputer Sterilizer ControlSybron Corp. · 1982
- 5 generations backK970907 Castle Series 100 Steam Sterilizers (Straightline)Getinge/Castle, Inc. · 1997
- 4 generations backK994314 Castle Series 100HC Steam SterilizersGetinge/Castle, Inc. · 2000
- 3 generations backK012573 Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC…Getinge/Castle, Inc. · 2001
- 2 generations backK030789 Amsco Century Steam SterilizerSTERIS Corporation · 2003
- 1 generation backK120149 Skyron Integrity 215 Steam Sterilizer Skytron Integrity 215 SG Steam…Sakura Seiki Co., Ltd. · 2012
- This deviceK132439 Sakura Steam Sterilizer Assr; -AO12, -A012W, -AO12P,-AO12PW /…Sakura Seiki Co., Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K820783 | Castle Microcomputer Sterilizer Control | Sybron Corp. | 1982 | — |
| −5 | K970907 | Castle Series 100 Steam Sterilizers (Straightline) | Getinge/Castle, Inc. | 1997 | — |
| −4 | K994314 | Castle Series 100HC Steam Sterilizers | Getinge/Castle, Inc. | 2000 | — |
| −3 | K012573 | Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and… | Getinge/Castle, Inc. | 2001 | — |
| −2 | K030789 | Amsco Century Steam Sterilizer | STERIS Corporation | 2003 | — |
| −1 | K120149 | Skyron Integrity 215 Steam Sterilizer Skytron Integrity 215 SG Steam… | Sakura Seiki Co., Ltd. | 2012 | — |
| 0 (this device) | K132439 | Sakura Steam Sterilizer Assr; -AO12, -A012W, -AO12P,-AO12PW / Skytron… | Sakura Seiki Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K120149 | Skyron Integrity 215 Steam Sterilizer Skytron Integrity 215 SG Steam Sterilizer Sakura…Summary page 1…Sterilizer, Steam 4. Predicate Device Information: Skytron Integrity 215 Steam Sterilizer, Skytron Integrity 215 SG Steam Sterilizer, K120149 5. Description: The Sakura Steam Sterilizer ASSR-AO1 2, Sakura Steam Sterilizer ASSR- AO12W, Sakura Steam St… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 18, 2019 | Class II | Z-1779-2019 | Device Design | Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K120149.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 ASSR-A012, ASSR-AO1 2W, ASSR-AO12P and ASSR-A01 2PW / Skytron Integrity 270 and 270 VP Steam Sterilizer are designed and optimized for use in health care facilities. Sakura Steam Sterilizer ASSR-A01 2, ASSR-AOI 2W, ASSR-AO1 2P and ASSR-AO1 2PWI/ Skytron Integrity 270 and 270 VP Steam Sterilizer incorporate high-pressure steam to sterilize non-porous and porous, heat and moisture-stable items and materials used in the health care…
Read the full statement (110 words)
Sakura Steam Sterilizer ASSR-A012, ASSR-AO1 2W, ASSR-AO12P and ASSR-A01 2PW / Skytron Integrity 270 and 270 VP Steam Sterilizer are designed and optimized for use in health care facilities. Sakura Steam Sterilizer ASSR-A01 2, ASSR-AOI 2W, ASSR-AO1 2P and ASSR-AO1 2PWI/ Skytron Integrity 270 and 270 VP 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 ASSR-A01 2, ASSR-AO1 2W, ASSR-AO1 2P and ASSR-AOI 2PW / Skytron Integrity 270 and 270 VP Steam Sterilizer are available in the following configuration.
26.5" x 37.5" x 53" chamber size, Single or Double Door Prevacuum and Gravity
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132439: Sakura Steam Sterilizer Assr; -AO12, -A012W, -AO12P,-AO12PW / Skytron Integrity 270;Steam Sterilizer,VP Steam Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132439
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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