510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K250059Substantially Equivalent

BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)

Becton Dickinson & Co, Franklin Lakes NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250059 is the FDA 510(k) clearance record for BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O), a class II device, cleared for Becton, Dickinson and Company 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 345 510(k) clearances for Becton, Dickinson and Company, from to . As of , FDA records show no recalls naming K250059.

Clearance record

Decision date
Received
(245 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
Becton, Dickinson and Company 1 Becton Dr., Franklin Lakes NJ
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