# K122774: Sakura Steam Sterilizaer Model Assv-AH06; Sakura Steam Sterilizer Model Assv-AH06E; Skytron Integrity 175; Skytron Integ

- Pathway: 510(k) (Traditional)
- Applicant: Sakura Seiki Co., Ltd.
- Decided: May 9, 2013 after 241 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: 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.

## Indications for use
Sakura Steam Sterilizer ASSV-AH06SI Skytron Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AHO6E / Skytron Integrity 175 SG Steam Sterilizers are designed and optimized for use in health care facilities. Sakura Steam Sterilizer ASSV-AHO6 / Skytron Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AHO6E / Skytron Integrity 175 SG Steam Sterilizers 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-AH06 / Skytron Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E / Skytron Integrity 175 SG Steam Sterilizers are available in the following configuration. 17.5" x 17.5" x 26.5' chamber size, Single Door Prevacuum and Gravity. Note: Sakura Steam Sterilizer ASSV-AHO6E / SKYTRON Integrity 176 SG Steam Sterilizers equip the Integrated steam generator.

Source page: https://510kreport.com/device/K122774
Methodology: https://510kreport.com/methodology