FDA product code ONB: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
ONB is the FDA product code for closed antineoplastic and hazardous drug reconstitution and transfer system. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel. FDA has cleared 41 510(k) submissions under ONB, 18 in the last five years, from 13 different applicants. The average 510(k) review took 198 days (median 175); 129 days on average over the last three years. FDA has posted 73 recalls for ONB devices, 48 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Device class | Class II |
| Regulation | 21 CFR 880.5440 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for ONB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 94 |
| 2018 | 6 | 289 |
| 2019 | 1 | 266 |
| 2020 | 3 | 231 |
| 2021 | 3 | 259 |
| 2022 | 1 | 904 |
| 2023 | 3 | 178 |
| 2024 | 8 | 157 |
| 2025 | 6 | 101 |
Compare with all 510(k) review times · Search every ONB clearance
Top ONB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Epic Medical Pte. , Ltd. | 12 | 2025-12-05 |
| Simplivia Healthcare , Ltd. | 6 | 2025-10-21 |
| Becton, Dickinson and Company | 4 | 2025-09-12 |
| Equashield Medical , Ltd. | 4 | 2023-02-17 |
| Teva Medical Ltd., Migada Plant | 3 | 2018-09-21 |
8 more applicants have ONB clearances. See the full list in Caduvo.
Most recent ONB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251722 | Epic Medical Pte. , Ltd. | ProSeal Transfer Injector (421120, 421130, 421140) | 2025-12-05 | 184 |
| K253033 | Simplivia Healthcare , Ltd. | Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor | 2025-10-21 | 29 |
| K250059 | Becton, Dickinson and Company | BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) | 2025-09-12 | 245 |
| K251411 | Simplivia Healthcare , Ltd. | Chemfort Female Luer Lock Adaptor | 2025-08-05 | 90 |
| K251340 | Epic Medical Pte. , Ltd. | ProSeal Bag Spike with Additive Port (423370ST, 423370) | 2025-05-29 | 29 |
Recalls for ONB devices
73 product recalls in 14 recall events; 48 initiated in the last five years and 63 still open. Most recent: 2026-05-12.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2020 | 4 |
| 2021 | 11 |
| 2022 | 4 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 39 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code ONB?
ONB is the FDA product code for closed antineoplastic and hazardous drug reconstitution and transfer system. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel.
What device class is ONB?
Class II, regulation 21 CFR 880.5440. Typical premarket route: 510(k).
How long does a 510(k) take for product code ONB?
Across 41 cleared submissions the average was 198 days from receipt to decision (median 175).
Which companies have the most ONB clearances?
Epic Medical Pte. , Ltd. (12); Simplivia Healthcare , Ltd. (6); Becton, Dickinson and Company (4); Equashield Medical , Ltd. (4); Teva Medical Ltd., Migada Plant (3).
Have ONB devices been recalled?
Yes: 73 product recalls across 14 recall events; the most recent began 2026-05-12.
Next steps
- Run an FDA pathway report with predicate devices for product code ONB
- Run a recall and safety report across every ONB manufacturer
- Watch product code ONB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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