Cleared Traditional

BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE (K011967) - FDA 510(k) Clearance

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

K011967 · Bd · General Hospital
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Jan 2002
Decision
212d
Days
Class 2
Risk

K011967 is an FDA 510(k) clearance for the BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Bd (Franklin Lakes, US). The FDA issued a Cleared decision on January 23, 2002 after a review of 212 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.

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Submission Details

510(k) Number K011967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2001
Decision Date January 23, 2002
Days to Decision 212 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
83d slower than avg
Panel avg: 129d · This submission: 212d
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 131
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K011967.
PEDIATRIC CENTRAL VENOUS CATHETER KIT
K023253 · B.Braun Medical, Inc. · May 2003
INTROCAN SAFETY IV CATHETER
K020785 · B.Braun Medical, Inc. · Aug 2002
TRIPLE LUMEN CENTRAL VENOUS CATHETER
K013182 · Cook, Inc. · Jul 2002
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
K003553 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 2001
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
K010034 · Cook, Inc. · Jan 2001
HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML
K003245 · Baxter Healthcare Corp · Dec 2000