510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K120149Substantially Equivalent

Skyron Integrity 215 Steam Sterilizer Skytron Integrity 215 Sg Steam Sterilizer Sakura Steam Sterilizer Assv-Ab09 Sakura

Sakura Seiki Co., Ltd., Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120149 is the FDA 510(k) clearance record for SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA, a class II device, cleared for Sakura Seiki Co., Ltd. on under FDA product code FLE (Sterilizer, Steam). FDA records list 3 510(k) clearances for Sakura Seiki Co., Ltd., from to . As of , FDA records show no recalls naming K120149.

Clearance record

Decision date
Received
(111 days to decision)
Product code
FLE Sterilizer, Steam
Regulation
21 CFR 880.6880
Device class
Class II
Review panel
General Hospital
Applicant
Sakura Seiki Co., Ltd. 55 Northern Blvd., Suite 200, Great Neck NY
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code FLE

Trailing 12 months
4 clearances under product code FLE in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FLE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20261
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260