# K002142: Saline IV Flush Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Emt-Rx
- Decided: Jan 28, 2002 after 560 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: 2 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032417: Heparin Lock Flush Syringe (2003), 0 descendants of its own

## Recalls of this device
- Jul 30, 2007 · Not classified · Z-1235-2007: Particulate matter in product.
- Jul 30, 2007 · Not classified · Z-1236-2007: Particulate matter in product.

Source page: https://510kreport.com/device/K002142
Methodology: https://510kreport.com/methodology