Cleared Traditional

MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML (K092491) - FDA 510(k) Clearance

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

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K092491 · Medefil, Inc. · General Hospital
Download Printable Device Report (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.

View all Medefil, Inc. devices

Submission Details

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.

Device Classification

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.