# K120149: Skyron Integrity 215 Steam Sterilizer Skytron Integrity 215 SG Steam Sterilizer Sakura Steam Sterilizer Assv-AB09 Sakura

- Pathway: 510(k) (Traditional)
- Applicant: Sakura Seiki Co., Ltd.
- Decided: May 8, 2012 after 111 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K820783 (1982). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030789: Amsco Century Steam Sterilizer, STERIS Corporation (2003) Summary page 1.

## Most influential descendants
- K132439: Sakura Steam Sterilizer Assr; -AO12, -A012W, -AO12P,-AO12PW / Skytron Integrity 270;Steam Sterilizer,VP Steam Sterilizer (2014), 0 descendants of its own
- K122774: Sakura Steam Sterilizaer Model Assv-AH06; Sakura Steam Sterilizer Model Assv-AH06E; Skytron Integrity 175; Skytron Integ (2013), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K120149
Methodology: https://510kreport.com/methodology