# K132439: Sakura Steam Sterilizer Assr; -AO12, -A012W, -AO12P,-AO12PW / Skytron Integrity 270;Steam Sterilizer,VP Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Sakura Seiki Co., Ltd.
- Decided: Jan 6, 2014 after 154 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K820783 (1982). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120149: Skyron Integrity 215 Steam Sterilizer Skytron Integrity 215 SG Steam Sterilizer Sakura Steam Sterilizer Assv-AB09 Sakura, Sakura Seiki Co., Ltd. (2012) Summary page 1.

## Recalls of this device
- Apr 18, 2019 · Class II · Z-1779-2019: Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure

## Indications for use
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

Source page: https://510kreport.com/device/K132439
Methodology: https://510kreport.com/methodology