FDA Product Code
FDA Product Code ONB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5440
510(k) Clearances — 41 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251722 | ProSeal Transfer Injector (421120, 421130, 421140) | Epic Medical Pte. , Ltd. | 2025-12-05 | Special | PDF ↗ |
| K253033 | Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor | Simplivia Healthcare , Ltd. | 2025-10-21 | Special | PDF ↗ |
| K250059 | BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) | Becton, Dickinson and Company | 2025-09-12 | Traditional | PDF ↗ |
| K251411 | Chemfort Female Luer Lock Adaptor | Simplivia Healthcare , Ltd. | 2025-08-05 | Traditional | PDF ↗ |
| K251340 | ProSeal Bag Spike with Additive Port (423370ST, 423370) | Epic Medical Pte. , Ltd. | 2025-05-29 | Special | PDF ↗ |
| K243976 | ZeroClear Bag Access (423100) | Epic Medical Pte. , Ltd. | 2025-01-22 | Special | PDF ↗ |
| K240517 | ProSeal Vented Universal Vial Adaptor | Epic Medical Pte. , Ltd. | 2024-12-26 | Traditional | PDF ↗ |
| K241988 | ProSeal Closed System Bag Access | Epic Medical Pte. , Ltd. | 2024-10-23 | Traditional | PDF ↗ |
| K241735 | ProSeal In Line Pump Set (423850) | Epic Medical Pte. , Ltd. | 2024-10-10 | Special | PDF ↗ |
| K241823 | ToxiSeal Vial Adaptor | Epic Medical Pte. , Ltd. | 2024-08-30 | Special | PDF ↗ |
| K241476 | ToxiSeal Vial Adaptor with External Flip Balloon | Epic Medical Pte. , Ltd. | 2024-06-21 | Special | PDF ↗ |
| K240433 | ProSeal Injection Site Extended Male Luer Lock (422140) | Epic Medical Pte. , Ltd. | 2024-05-21 | Traditional | PDF ↗ |
| K240171 | ProSeal Injector Plus (Model no. 421050) | Epic Medical Pte. , Ltd. | 2024-03-28 | Special | PDF ↗ |
| K222929 | ToxiSeal Vial Adapter with External Balloon | Epic Medical Pte. , Ltd. | 2024-01-11 | Traditional | PDF ↗ |
| K231286 | Chemfort® Catheter Adaptor | Simplivia Healthcare , Ltd. | 2023-08-02 | Traditional | PDF ↗ |
| K223076 | BD Texium Closed Male Luer | Care Fusion | 2023-03-24 | Traditional | PDF ↗ |
| K221513 | Equashield Closed System Transfer Device | Equashield Medical , Ltd. | 2023-02-17 | Traditional | PDF ↗ |
| K201460 | Closed System Transfer Device | Shinva Ande Healthcare Apparatus Co., Ltd. | 2022-11-23 | Traditional | PDF ↗ |
| K210707 | OnGuard2 Chemfort Closed Administration (CADM) | Simplivia Healthcare , Ltd. | 2021-09-23 | Traditional | PDF ↗ |
| K201422 | Arisure Closed System Drug Transfer Device (CSTD) | Yukon Medical, LLC | 2021-03-02 | Traditional | PDF ↗ |
| K201142 | 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 | Simplivia Healthcare , Ltd. | 2021-02-25 | Traditional | PDF ↗ |
| K201099 | BD PhaSeal Optima Closed System Drug Transfer Device | Becton, Dickinson and Company | 2020-08-12 | Special | PDF ↗ |
| K192075 | ProSeal Closed System drug Transfer Device (CSTD) | Epic Medical Pte. , Ltd. | 2020-08-07 | Traditional | PDF ↗ |
| K192866 | Chemfort CSTD | Simplivia Healthcare , Ltd. | 2020-05-07 | Abbreviated | PDF ↗ |
| K190157 | Diana ChemoClave Transfer Set | Icu Medical | 2019-10-23 | Traditional | PDF ↗ |
| K181221 | BD PhaSeal Optima Closed System Transfer Device | Becton, Dickinson and Company | 2018-11-30 | Traditional | PDF ↗ |
| K180489 | TEVADAPTOR Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | 2018-09-21 | Traditional | PDF ↗ |
| K173477 | ChemoCLAVE Cytotoxic Medication Preparation and Delivery System | Icu Medical, Inc. | 2018-08-31 | Traditional | PDF ↗ |
| K180574 | 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 | J & J Solutions, Inc. D/B/A/ Corvida Medical | 2018-08-17 | Traditional | PDF ↗ |
| K170110 | Diana Medication Transfer Set | Icu Medical, Inc. | 2018-08-10 | Traditional | PDF ↗ |
| K172499 | NEOSHIELD | JMS North America Corporation | 2018-06-01 | Traditional | PDF ↗ |
| K170706 | Equashield Closed System drug Transfer Device (CSTD) | Equashield Medical , Ltd. | 2017-07-03 | Traditional | PDF ↗ |
| K170680 | TEVADAPTOR Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | 2017-05-16 | Special | PDF ↗ |
| K150219 | Equashield Closed System drug Transfer Device (CSTD) | Equashield Medical , Ltd. | 2015-11-05 | Traditional | PDF ↗ |
| K150486 | Halo | J & J Solutions, Inc. D/B/A/ Corvida Medical | 2015-07-24 | Traditional | PDF ↗ |
| K141448 | TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM | Teva Medical Ltd., Migada Plant | 2015-01-23 | Abbreviated | PDF ↗ |
| K140591 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR | Becton, Dickinson & CO | 2014-05-14 | Special | PDF ↗ |
| K132899 | EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) | Equashield Medical , Ltd. | 2014-05-13 | Traditional | PDF ↗ |
| K131549 | CHEMOLOCK, CHEMOLOCK PORT | Icu Medical, Inc. | 2013-07-26 | Traditional | PDF ↗ |
| K130197 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55 | Becton, Dickinson and Company | 2013-02-27 | Special | PDF ↗ |
| K123213 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE | Becton, Dickinson & CO | 2013-01-09 | Traditional | PDF ↗ |
Product code ONB · Class II · General Hospital. Data: openFDA.