# K911732: Advance Disposable Control Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Advance Medical Designs, Inc.
- Decided: Sep 16, 1991 after 152 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jun 27, 2005 · Not classified · Z-1078-05: The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip.
- Jun 27, 2005 · Not classified · Z-1076-05: The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip.
- Jun 27, 2005 · Not classified · Z-1077-05: The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip.

Source page: https://510kreport.com/device/K911732
Methodology: https://510kreport.com/methodology