Chrysalis Intelligence · Product Codes · ONB

ONB · Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

General Hospital · 24 clearances · 7 unique sponsors

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Device class
Class II
Regulation 880.5440
Total clearances
24
2020-05-07 → 2025-12-05
Last 12 months
2
Unique sponsors
7
Definition

What is Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.
Classification details
Medical specialty
General Hospital
Review panel
HO
Regulation number
880.5440
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Epic Medical Pte. , Ltd. 12 1 2025-12-05
Simplivia Healthcare , Ltd. 6 1 2025-10-21
Becton, Dickinson and Company 2 0 2025-09-12
Yukon Medical, LLC 1 0 2021-03-02
Equashield Medical , Ltd. 1 0 2023-02-17
Care Fusion 1 0 2023-03-24
Shinva Ande Healthcare Apparatus Co., Ltd. 1 0 2022-11-23
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
Q2699 HCPCS — Medium Unlisted/not otherwise classified device or supply for hazardous drug handling
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-12-05 K251722 Epic Medical Pte. , Ltd. ProSeal™ Transfer Injector (421120, 421130, 421140)
2025-10-21 K253033 Simplivia Healthcare , Ltd. Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
2025-09-12 K250059 Becton, Dickinson and Company BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)
2025-08-05 K251411 Simplivia Healthcare , Ltd. Chemfort Female Luer Lock Adaptor
2025-05-29 K251340 Epic Medical Pte. , Ltd. ProSeal™ Bag Spike with Additive Port (423370ST, 423370)
2025-01-22 K243976 Epic Medical Pte. , Ltd. ZeroClear™ Bag Access (423100)
2024-12-26 K240517 Epic Medical Pte. , Ltd. ProSeal™ Vented Universal Vial Adaptor
2024-10-23 K241988 Epic Medical Pte. , Ltd. ProSeal™ Closed System Bag Access
2024-10-10 K241735 Epic Medical Pte. , Ltd. ProSeal™ In Line Pump Set (423850)
2024-08-30 K241823 Epic Medical Pte. , Ltd. ToxiSeal™ Vial Adaptor
2024-06-21 K241476 Epic Medical Pte. , Ltd. ToxiSeal™ Vial Adaptor with External Flip Balloon
2024-05-21 K240433 Epic Medical Pte. , Ltd. ProSeal™ Injection Site Extended Male Luer Lock (422140)
2024-03-28 K240171 Epic Medical Pte. , Ltd. ProSeal™ Injector Plus (Model no. 421050)
2024-01-11 K222929 Epic Medical Pte. , Ltd. ToxiSeal Vial Adapter with External Balloon
2023-08-02 K231286 Simplivia Healthcare , Ltd. Chemfort® Catheter Adaptor
2023-03-24 K223076 Care Fusion BD Texium™ Closed Male Luer
2023-02-17 K221513 Equashield Medical , Ltd. Equashield Closed System Transfer Device
2022-11-23 K201460 Shinva Ande Healthcare Apparatus Co., Ltd. Closed System Transfer Device
2021-09-23 K210707 Simplivia Healthcare , Ltd. OnGuard2 Chemfort Closed Administration (CADM)
2021-03-02 K201422 Yukon Medical, LLC Arisure Closed System Drug Transfer Device (CSTD)
2021-02-25 K201142 Simplivia Healthcare , Ltd. TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set
2020-08-12 K201099 Becton, Dickinson and Company BD PhaSeal Optima Closed System Drug Transfer Device
2020-08-07 K192075 Epic Medical Pte. , Ltd. ProSeal™ Closed System drug Transfer Device (CSTD)
2020-05-07 K192866 Simplivia Healthcare , Ltd. Chemfort CSTD
Data source: openFDA · Generated 2026-10-08 10:51 · Last ingest 2026-10-08T14:51:39.242493 · Pipeline: Chrysalis Intelligence