Product code NGT— General Hospital
AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
- Classification name
- Saline, Vascular Access Flush
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Total cleared
- 41
- First cleared
- Most recent
FDA classification definition
“Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.”
Market context for product code NGT
FDA has cleared devices under product code NGT between 2001 and 2025, filed by 24 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2024
- 2023
- 2022
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
Top applicants under product code NGT
Adverse events under product code NGT
product code NGT- Death
- 12
- Malfunction
- 2,008
- Other
- 4
- Total
- 2,024
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code NGT
- K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe
- K233623 — Praxiject SP 0.9% NaCl
- K231724 — Flush Syringe (Prefilled 0.9% normal saline solution)
- K231363 — Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
- K223584 — Pre-Filled Normal Saline Flush Syringe
- K230756 — TK Pre-Filled Normal Saline Flush Syringe
- K231161 — 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe
- K231754 — Praxiject 0.9% NaCl
- K214080 — Pentaflush
- K220060 — Pre-filled Syringe with Saline
- K213522 — AMSafe Pre-Filled Normal Saline Flush Syringe
- 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
- K192414 — Praxiject 0.9% NaCl
- K191378 — 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe
- K183473 — AMSafe(R) Pre-Filled Normal Saline Flush Syringe
- K173348 — 0.9% Sodium Chloride Injection, USP
- K171109 — Praxiject 0.9% NaCl
- K161552 — 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe
- K153481 — 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe
- K150143 — Normal Saline Flush
- K142620 — 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe
- K133685 — 0.9% SODIUM CHLORIDE FLUSH SYRINGE
- K141311 — 0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE
- K121050 — 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE
- K121262 — MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY
- K121231 — IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST
- K120836 — 0.9% SODIUM CHLORIDE FLISH SYRINGE
- K113555 — AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
- K103740 — SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
- K111034 — AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
- K101270 — SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311
- K090882 — FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE
- K091583 — MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE
- K082689 — STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
- K082837 — STERILE FIELD SALINE PRE-FILLED SYRINGE(S)
- K060339 — KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY
- K042061 — 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE
- K032438 — MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE
- K020996 — MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL
- K020999 — MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL
- K011283 — MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.