DeviceClearance

Product code ONB— General Hospital

Equashield Closed System drug Transfer Device (CSTD)

Classification name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device class
Class 2
Regulation
21 CFR 880.5440
Advisory panel
General Hospital
Total cleared
41
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code ONB under 21 CFR 880.5440, via openFDA

Market context for product code ONB

FDA has cleared 41 devices under product code ONB between 2013 and 2025, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code ONB

Adverse events under product code ONB

product code ONB
Malfunction
3,615
Other
13
Total
3,628

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code ONB

Data sourced from openFDA. This site is unofficial and independent of the FDA.