# K082837: Sterile Field Saline Pre-Filled Syringe (S)

- Pathway: 510(k) (Special)
- Applicant: Excelsior Medical Corp.
- Decided: Dec 18, 2008 after 83 days
- Product code: NGT (Saline, Vascular Access Flush)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K053120 (2005). 1 ancestor in all.
9 later devices descend from it; 3 cite it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053120: Sterile Field Saline and Heparin Lock Flush Syringes, Excelsior Medical Corp. (2005) Summary page 1.
- (no number) Excelsior Medical Heparin Lock Flush Syringe (1 U/mL and 2 U/mL): named in the summary without a submission number

## Most influential descendants
- K171109: Praxiject 0.9% NaCl (2017), 6 descendants of its own
- K192414: Praxiject 0.9% NaCl (2020), 3 descendants of its own
- K231754: Praxiject™ 0.9% NaCl (2023), 1 descendant of its own
- K201286: 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch (2020), 1 descendant of its own
- K243484: PM2+ System and SmartPICC Stylet (2025), 0 descendants of its own

## Recalls of this device
- Mar 4, 2022 · Class II · Z-0898-2022: Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.

## Indications for use
Excelsior Sterile Field Saline Flush Syringe(s) are intended for use in flushing IV catheters and IV tubing.

Source page: https://510kreport.com/device/K082837
Methodology: https://510kreport.com/methodology