Cleared Traditional

K812137 - B-D HEPARINIZED LONGDWEL I.V. CATHETER

K812137 is the FDA 510(k) clearance for B-D HEPARINIZED LONGDWEL I.V. CATHETER by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K812137 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
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Nov 1981
Decision
101d
Days
Class 2
Risk

K812137 is an FDA 510(k) clearance for the B-D HEPARINIZED LONGDWEL I.V. CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on November 6, 1981 after a review of 101 days - within the typical 510(k) review window.

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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K812137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1981
Decision Date November 06, 1981
Days to Decision 101 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 129d · This submission: 101d
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 274
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K812137.
DESERET INTRACATH INTRAVENOUS CATHETER
K821372 · Warner-Lambert Co. · Jun 1982
CRITIKON I.V. CATHETER PLACEMENT UNIT
K813345 · Critikon Company, LLC · Jan 1982
VERSCHLUBSTOPFEN COMB-CLOSING STOPPER
K813396 · Burron Medical Products, Inc. · Jan 1982
INTRAVASCULAR CATHETER
K803238 · G.D. Searle and Co. · Apr 1981
BURRON MICROCATH INTRA. CATH. PLACEMENTT
K801941 · Burron Medical Products, Inc. · Aug 1980
ERYTHROCATH INTRAVENOUS CATHETER PLA. U.
K801414 · G.D. Searle and Co. · Aug 1980