FDA product code · General Hospital · Class 2
ONB: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
ONB is FDA's product code for "Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System": a Class 2 device classified under 21 CFR 880.5440, reviewed by the General Hospital panel.
510(k) review time for ONB
Across 31 510(k) clearances under ONB decided from 2018-01-01 to 2026-10-06, the median was 197 days from FDA receipt to decision. Half took between 94 and 282 days, and 80% were decided within 291 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 94 |
| Median | 197 |
| 75th percentile | 282 |
| 80th percentile | 291 |
| 90th percentile | 371 |
| Slowest | 904 |
| Year | Median days | n |
|---|---|---|
| 2018 | 249 | 6 |
| 2024 | 102 | 8 |
| 2025 | 60 | 6 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
ONB in the public FDA record
| 510(k) clearances, all years | 41 |
|---|---|
| Device recalls | 73 |
| Establishment listings | 129 |
| GUDID device identifiers | 458 |
Counts of records, not of devices or events. Adverse event reports for ONB are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite ONB
2 FDA recognized consensus standards cite ONB, among them ISO 23908 First edition 2011-06-11; ISO 23908 Second Edition 2024-12. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 6-273 ISO 23908 First edition 2011-06-11 — Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles introducers for catheters and needles used for blood sampling
- 6-507 ISO 23908 Second Edition 2024-12 — Sharps injury protection - Sharps protection mechanisms for single-use needles introducers for catheters and needles used for blood testing monitoring sampling and medical substance administration - Requirements and test methods
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.