Cleared Traditional

K013556 - MONOJECT PREFILL HEPARIN LOCK FLUSH SYR...

K013556 is the FDA 510(k) clearance for MONOJECT PREFILL HEPARIN LOCK FLUSH SYR... by Tyco Healthcare. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K013556 · Tyco Healthcare · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
67d
Days
Class 2
Risk

K013556 is an FDA 510(k) clearance for the MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on December 31, 2001 after a review of 67 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tyco Healthcare devices

Submission Details

510(k) Number K013556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2001
Decision Date December 31, 2001
Days to Decision 67 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
62d faster than avg
Panel avg: 129d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 241
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K013556.
INTROCAN SAFETY IV CATHETER
K020785 · B.Braun Medical, Inc. · Aug 2002
TRIPLE LUMEN CENTRAL VENOUS CATHETER
K013182 · Cook, Inc. · Jul 2002
TRULINE REINFORCED VALVED INFUSION CATHETER
K021139 · Micro Therapeutics, Inc. · Apr 2002
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE
K013800 · Becton Dickinson Infusion Therapy Systems, Inc. · Dec 2001
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS
K013073 · Becton Dickinson Infusion Therapy Systems, Inc. · Nov 2001
TRULINE INFUSION CATHETERS
K011937 · Micro Therapeutics, Inc. · Aug 2001