510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192866Substantially Equivalent

Chemfort CSTD

Simplivia Healthcare Ltd., Kiryat Shmona, IL / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192866 is the FDA 510(k) clearance record for Chemfort CSTD, a class II device, cleared for Simplivia Healthcare , Ltd. on under FDA product code ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System). FDA's definition for product code ONB reads: "Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting". FDA records list 22 510(k) clearances for Simplivia Healthcare , Ltd., from to . As of , FDA records show one recall naming K192866.

Clearance record

Decision date
Received
(213 days to decision)
Product code
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Simplivia Healthcare , Ltd. North Industrial Zone, Kiryat Shmona, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ONB

Trailing 12 months
1 clearance under product code ONB 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 ONB, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260