SAKURA STEAM STERILIZER ASSR +2 more— 510(k) K132439

Clearance details

Device name as filed

SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER

Applicant

Sakura Seiki Co., Ltd.

Product code

Code FLE

Device class

Class 2

Regulation

21 CFR 880.6880

Advisory panel

General Hospital

Date received

2013-08-05

Decision date

2014-01-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Great Neck, NY, US

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• K122774 — SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 1752013-05-09
• K120149 — SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA2012-05-08

Malfunction

444

Total

444

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1779-2019 — Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industryClass II·Terminated·Skytron, Div. The KMW Group, Inc·20190418

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132439.