Cleared Traditional

K011967 - BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9...

K011967 is an FDA 510(k) clearance for BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9..., manufactured by Bd. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K011967 · Bd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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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FDA 510(k) Submission Details - K011967

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.

FOZ Device Classification - Class 2, Special Controls

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

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