Cleared Special

K111034 - AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE

K111034 is an FDA 510(k) clearance for AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE, manufactured by Am USA. The device is a Class 2 General Hospital device with product code NGT cleared through the Special 510(k) pathway after a 92-day FDA review.

K111034 · Am USA · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
92d
Days
Class 2
Risk

K111034 is an FDA 510(k) clearance for the AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE. Classified as Saline, Vascular Access Flush (product code NGT), Class II - Special Controls.

Submitted by Am USA (Nashville, US). The FDA issued a Cleared decision on July 14, 2011 after a review of 92 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K111034

510(k) Number K111034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2011
Decision Date July 14, 2011
Days to Decision 92 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 129d · This submission: 92d
Pathway characteristics
Modification to existing cleared device.

NGT Device Classification - Class 2, Special Controls

Product Code NGT Saline, Vascular Access Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
Definition Enhance The Performance Of Intravascular Catheters, To Maintain Patency Of The Vascular Catheter When It Is Not In Use.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - NGT Saline, Vascular Access Flush

All 40
Devices cleared under the same product code (NGT) and FDA review panel - the closest regulatory comparables to K111034.
0.9% SODIUM CHLORIDE FLISH SYRINGE
K120836 · Am USA · Jul 2012
AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
K113555 · Am USA · Jan 2012
SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
K103740 · Spectra Medical Devices, Inc. · Jul 2011
SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311
K101270 · Excelsior Medical Corp. · Feb 2011
FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE
K090882 · Hospira, Inc. · Apr 2010
MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE
K091583 · Medefil, Inc. · Jan 2010
K111034 · AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
Download PDF FDA Summary Am USA