Cleared Traditional

K082689 - STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE

K082689 is an FDA 510(k) clearance for STERILE SODIUM CHLORIDE 0.9% FLUSH, manufactured by Spectra Medical Devices, Inc.. The device is a Class 2 General Hospital device with product code NGT cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K082689 · Spectra Medical Devices, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
186d
Days
Class 2
Risk

K082689 is an FDA 510(k) clearance for the STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE. Classified as Saline, Vascular Access Flush (product code NGT), Class II - Special Controls.

Submitted by Spectra Medical Devices, Inc. (Washington, US). The FDA issued a Cleared decision on March 20, 2009 after a review of 186 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K082689

510(k) Number K082689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2008
Decision Date March 20, 2009
Days to Decision 186 days
Submission Type Traditional
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
57d slower than avg
Panel avg: 129d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K082689.
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
STERILE FIELD SALINE PRE-FILLED SYRINGE(S)
K082837 · Excelsior Medical Corp. · Dec 2008
KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY
K060339 · Tyco Healthcare/Kendall · Apr 2006
0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE
K042061 · Becton Dickinson · Aug 2004