# K060339: Kendall Monoject Pre-Fill Advanced 0.9%Sodium Chloride Flush Syringes for Sterile Delivery

- Pathway: 510(k) (Special)
- Applicant: Tyco Healthcare/Kendall
- Decided: Apr 28, 2006 after 77 days
- Product code: NGT (Saline, Vascular Access Flush)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003245 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032438: Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush Syringe, Tyco Healthcare (2004) Summary page 1.

## Recalls of this device
- Aug 6, 2015 · Class II · Z-2527-2015: Sterility may be compromised
- Aug 6, 2015 · Class II · Z-2530-2015: Sterility may be compromised
- Aug 6, 2015 · Class II · Z-2526-2015: Sterility may be compromised
- Aug 6, 2015 · Class II · Z-2533-2015: Sterility may be compromised
- Aug 6, 2015 · Class II · Z-2531-2015: Sterility may be compromised
- Aug 6, 2015 · Class II · Z-2534-2015: Sterility may be compromised
- Aug 6, 2015 · Class II · Z-2529-2015: Sterility may be compromised
- Aug 6, 2015 · Class II · Z-2535-2015: Sterility may be compromised
- Aug 6, 2015 · Class II · Z-2525-2015: Sterility may be compromised
- Aug 6, 2015 · Class II · Z-2528-2015: Sterility may be compromised
- Aug 6, 2015 · Class II · Z-2536-2015: Sterility may be compromised

## Indications for use
Kendall Monoject PreFill ADVANCED 0.9% Sodium Chloride Flush Syringes for Sterile Delivery is indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

Source page: https://510kreport.com/device/K060339
Methodology: https://510kreport.com/methodology