FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE— 510(k) K090882

Clearance details

Applicant

Hospira, Inc.

Product code

Code NGT

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2009-03-31

Decision date

2010-04-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lake Forest, IL, US

• K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe2025-12-02
• K233623 — Praxiject SP 0.9% NaCl2024-02-27
• K231724 — Flush Syringe (Prefilled 0.9% normal saline solution)2023-11-09
• K231363 — Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)2023-09-27
• K223584 — Pre-Filled Normal Saline Flush Syringe2023-08-12

• K161469 — Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module2017-03-28
• K161036 — Hospira Extension Set, Hospira Primary Set2017-01-06
• K160492 — Hospira Sapphire Sets2016-12-06
• K160870 — Hospira Administration Sets2016-06-01
• K143612 — LifeCare PCA Infusion System2016-04-08

Death

12

Malfunction

2,008

Other

4

Total

2,024

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0663-2013 — Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.Class II·Terminated·Merit Medical Systems, Inc.·20120914

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090882.