Chrysalis Intelligence · Product Codes · ONB

ONB · Unclassified

24 clearances · 7 unique sponsors

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Device class
—
Regulation —
Total clearances
24
2020-05-07 → 2025-12-05
Last 12 months
3
Unique sponsors
7
Classification details
Medical specialty
—
Review panel
—
Regulation number
—
Implant
—
Life-sustain / support
—
GMP exempt
—
Third-party review
—
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 1 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 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence