Cleared Traditional

K092491 - MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML

Also marketed or referenced as:
10 UNITS/ML AND 100 UNITS/ML IN VARIOUS FILL SIZES

K092491 is an FDA 510(k) clearance for MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 ..., manufactured by Medefil, Inc.. The device is a Class 2 General Hospital device with product code NZW cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K092491 · Medefil, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
174d
Days
Class 2
Risk

K092491 is an FDA 510(k) clearance for the MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML. Classified as Heparin, Vascular Access Flush (product code NZW), Class II - Special Controls.

Submitted by Medefil, Inc. (Glendale Heights, US). The FDA issued a Cleared decision on February 3, 2010 after a review of 174 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 - K092491

510(k) Number K092491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2009
Decision Date February 03, 2010
Days to Decision 174 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 129d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NZW Device Classification - Class 2, Special Controls

Product Code NZW Heparin, 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 - NZW Heparin, Vascular Access Flush

Devices cleared under the same product code (NZW) and FDA review panel - the closest regulatory comparables to K092491.
BD PosiFlush Heparin Lock Flush Syringe
K163591 · Becton, Dickinson and Company · Feb 2017
HEPARIN LOCK / FLUSH SYRINGES
K133446 · Excelsior Medical Corporation · Nov 2014
HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710
K092938 · App Pharmaceuticals, LLC · Jun 2010
HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE
K090680 · Becton, Dickinson & CO · Jun 2009
SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML
K061497 · Excelsior Medical Corp. · Feb 2007
SYREX PRE-FILLED SYRINGE
K023740 · Excelsior Medical Corp. · May 2003
K092491 · MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML
Download PDF FDA Summary Medefil, Inc.