# K001616: Modification to Syringe Prefilled with 0.9% Sodium Chloride

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Jul 27, 2000 after 63 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K090882: Flush Syringe Filled with 0.9% Sodium Chloride (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K001616
Methodology: https://510kreport.com/methodology