# K011283: Monoject Prefill 0.9% Sodium Chloride Flush Syringe

- Pathway: 510(k) (Traditional)
- Applicant: The Kendall Company
- Decided: Oct 15, 2001 after 171 days
- Product code: NGT (Saline, Vascular Access Flush)
- 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.
3 later devices descend from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has 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
- K032438: Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush Syringe (2004), 2 descendants of its own
- K090882: Flush Syringe Filled with 0.9% Sodium Chloride (2010), 0 descendants of its own
- K060339: Kendall Monoject Pre-Fill Advanced 0.9%Sodium Chloride Flush Syringes for Sterile Delivery (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K011283
Methodology: https://510kreport.com/methodology