Cleared Special

K113555 - AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE

K113555 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 60-day FDA review.

K113555 · Am USA · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
60d
Days
Class 2
Risk

K113555 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 January 30, 2012 after a review of 60 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 - K113555

510(k) Number K113555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2011
Decision Date January 30, 2012
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
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 K113555.
MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY
K121262 · Medefil, Inc. · Sep 2012
IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST
K121231 · Ind Ndiagnostic, Inc. · Jul 2012
0.9% SODIUM CHLORIDE FLISH SYRINGE
K120836 · Am USA · Jul 2012
SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
K103740 · Spectra Medical Devices, Inc. · Jul 2011
AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
K111034 · Am USA · Jul 2011
SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311
K101270 · Excelsior Medical Corp. · Feb 2011
K113555 · AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
Download PDF FDA Summary Am USA