SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE— 510(k) K103740

Clearance details

Applicant

Spectra Medical Devices, Inc.

Product code

Code NGT

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2010-12-22

Decision date

2011-07-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Washington, DC, 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

• K151069 — SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle2016-02-05
• K082689 — STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE2009-03-20
• K082580 — SPECTRA GUIDEWIRE INTRODUCER NEEDLE2008-12-08
• K082674 — SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE2008-11-28
• K081524 — SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L2008-07-29

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-2873-2026 — Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.Class I·Ongoing·Spectra Medical Devices, Llc·20260706

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103740.