# K090882: Flush Syringe Filled with 0.9% Sodium Chloride

- Pathway: 510(k) (Traditional)
- Applicant: Hospira, Inc.
- Decided: Apr 23, 2010 after 388 days
- Product code: NGT (Saline, Vascular Access Flush)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 3 (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). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001616: Modification to Syringe Prefilled with 0.9% Sodium Chloride, Abbott Laboratories (2000) Summary page 1.
- K953805: 0.9% Sodium Chloride Diluent in Plastic Syringe, Abbott Laboratories (1996) Summary page 1.
- 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
- Sep 14, 2012 · Class II · Z-0663-2013: Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed customer report where four separate particulate issues were identified in four individual 
- Nov 18, 2011 · Not classified · Z-0596-2012: There is particulate matter in the fluid pathway, which has been identified as the same material as the rubber tip of the syringe plunger.
- Sep 2, 2010 · Not classified · Z-0035-2011: There is the potential for a dimensional issue in 6 ml syringe products, codes E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, S5, to cause leakage and.or loss of sterility

## Indications for use
For the flushing and assessing the. patency of indwelling catheters and venipuncture devices which are designed for intermittent injection therapy, blood sampling, or fluid and nutritional therapy.

Source page: https://510kreport.com/device/K090882
Methodology: https://510kreport.com/methodology