Cleared Special

K082837 - STERILE FIELD SALINE PRE-FILLED SYRINGE(S)

K082837 is an FDA 510(k) clearance for STERILE FIELD SALINE PRE-FILLED SYRINGE(S), manufactured by Excelsior Medical Corp.. The device is a Class 2 General Hospital device with product code NGT cleared through the Special 510(k) pathway after a 83-day FDA review.

K082837 · Excelsior Medical Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
83d
Days
Class 2
Risk

K082837 is an FDA 510(k) clearance for the STERILE FIELD SALINE PRE-FILLED SYRINGE(S). Classified as Saline, Vascular Access Flush (product code NGT), Class II - Special Controls.

Submitted by Excelsior Medical Corp. (Neptune, US). The FDA issued a Cleared decision on December 18, 2008 after a review of 83 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 - K082837

510(k) Number K082837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2008
Decision Date December 18, 2008
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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 K082837.
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 SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
K082689 · Spectra Medical Devices, Inc. · Mar 2009
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
MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE
K032438 · Tyco Healthcare · Jun 2004
K082837 · STERILE FIELD SALINE PRE-FILLED SYRINGE(S)
Download PDF FDA Summary Excelsior Medical Cor…