BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)
FDA 510(k) K250059 · Becton, Dickinson and Company
510(k) numberK250059
Submission
- Device name
- BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)
- Applicant
- Becton, Dickinson and Company
Franklin Lakes, NJ, US - Received
- January 10, 2025
- Decision date
- September 12, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ONB – Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.
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Questions and answers
When was BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) cleared by the FDA?
BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) (K250059) received a 510(k) decision of Substantially Equivalent on September 12, 2025, 245 days after the submission was received.
What is the product code of K250059?
The FDA product code is ONB – Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System, a Class II (moderate risk) device regulated under 21 CFR 880.5440.