# 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

- Pathway: 510(k) (Traditional)
- Applicant: Nurse Assist, LLC
- Decided: Aug 11, 2020 after 89 days
- Product code: NGT (Saline, Vascular Access Flush)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K053120 (2005). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171109: Praxiject 0.9% NaCl, Medxl, Inc. (2017) Summary page 4.

## Most influential descendants
- K243484: PM2+ System and SmartPICC Stylet (2025), 0 descendants of its own

## Recalls of this device
- Nov 6, 2023 · Class I · Z-0512-2024: Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product
- Nov 6, 2023 · Class I · Z-0511-2024: Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product

## Indications for use
0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations for the appropriate device. May be placed on a sterile field.

Source page: https://510kreport.com/device/K201286
Methodology: https://510kreport.com/methodology