Atlas FDA

ONB

41 FDA 510(k) clearances · Product code

175 daysmedian time to decision
307 days90th percentile
41clearances measured

FDA profile

Official device name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Medical specialty
General Hospital
FDA definition
Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.
Adverse events (MAUDE)
2021: 548 · 2022: 448 · 2023: 456 · 2024: 686 · 2025: 947 · 2026: 424
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ProSeal™ Transfer Injector (421120, 421130, 421140) (K251722)Epic Medical Pte. , Ltd.2025-12-05
Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor (K253033)Simplivia Healthcare , Ltd.2025-10-21
BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) (K250059)Becton, Dickinson and Company2025-09-12
Chemfort Female Luer Lock Adaptor (K251411)Simplivia Healthcare , Ltd.2025-08-05
ProSeal™ Bag Spike with Additive Port (423370ST, 423370) (K251340)Epic Medical Pte. , Ltd.2025-05-29
ZeroClear™ Bag Access (423100) (K243976)Epic Medical Pte. , Ltd.2025-01-22
ProSeal™ Vented Universal Vial Adaptor (K240517)Epic Medical Pte. , Ltd.2024-12-26
ProSeal™ Closed System Bag Access (K241988)Epic Medical Pte. , Ltd.2024-10-23
ProSeal™ In Line Pump Set (423850) (K241735)Epic Medical Pte. , Ltd.2024-10-10
ToxiSeal™ Vial Adaptor (K241823)Epic Medical Pte. , Ltd.2024-08-30
ToxiSeal™ Vial Adaptor with External Flip Balloon (K241476)Epic Medical Pte. , Ltd.2024-06-21
ProSeal™ Injection Site Extended Male Luer Lock (422140) (K240433)Epic Medical Pte. , Ltd.2024-05-21
ProSeal™ Injector Plus (Model no. 421050) (K240171)Epic Medical Pte. , Ltd.2024-03-28
ToxiSeal Vial Adapter with External Balloon (K222929)Epic Medical Pte. , Ltd.2024-01-11
Chemfort® Catheter Adaptor (K231286)Simplivia Healthcare , Ltd.2023-08-02
BD Texium™ Closed Male Luer (K223076)Care Fusion2023-03-24
Equashield Closed System Transfer Device (K221513)Equashield Medical , Ltd.2023-02-17
Closed System Transfer Device (K201460)Shinva Ande Healthcare Apparatus Co., Ltd.2022-11-23
OnGuard2 Chemfort Closed Administration (CADM) (K210707)Simplivia Healthcare , Ltd.2021-09-23
Arisure Closed System Drug Transfer Device (CSTD) (K201422)Yukon Medical, LLC2021-03-02
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 (K201142)Simplivia Healthcare , Ltd.2021-02-25
BD PhaSeal Optima Closed System Drug Transfer Device (K201099)Becton, Dickinson and Company2020-08-12
ProSeal™ Closed System drug Transfer Device (CSTD) (K192075)Epic Medical Pte. , Ltd.2020-08-07
Chemfort CSTD (K192866)Simplivia Healthcare , Ltd.2020-05-07
Diana ChemoClave Transfer Set (K190157)Icu Medical2019-10-23
BD PhaSeal Optima Closed System Transfer Device (K181221)Becton, Dickinson and Company2018-11-30
TEVADAPTOR Closed Drug Reconstitution and Transfer System (K180489)Teva Medical Ltd., Migada Plant2018-09-21
ChemoCLAVE Cytotoxic Medication Preparation and Delivery System (K173477)Icu Medical, Inc.2018-08-31
Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor (K180574)J & J Solutions, Inc. D/B/A/ Corvida Medical2018-08-17
Diana Medication Transfer Set (K170110)Icu Medical, Inc.2018-08-10
NEOSHIELD (K172499)JMS North America Corporation2018-06-01
Equashield Closed System drug Transfer Device (CSTD) (K170706)Equashield Medical , Ltd.2017-07-03
TEVADAPTOR Closed Drug Reconstitution and Transfer System (K170680)Teva Medical Ltd., Migada Plant2017-05-16
Equashield Closed System drug Transfer Device (CSTD) (K150219)Equashield Medical , Ltd.2015-11-05
Halo (K150486)J & J Solutions, Inc. D/B/A/ Corvida Medical2015-07-24
TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM (K141448)Teva Medical Ltd., Migada Plant2015-01-23
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR (K140591)Becton, Dickinson & CO2014-05-14
EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) (K132899)Equashield Medical , Ltd.2014-05-13
CHEMOLOCK, CHEMOLOCK PORT (K131549)Icu Medical, Inc.2013-07-26
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55 (K130197)Becton, Dickinson and Company2013-02-27
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE (K123213)Becton, Dickinson & CO2013-01-09

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Every clearance here is in the API, with alerts when new ones post.