Cleared Traditional

B-D HEPARINIZED LONGDWEL I.V. CATHETER (K812137) - FDA 510(k) Clearance

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

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 124
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K812137.
INJECTION CAP
K834480 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1984
INJECTION SEALING CAP 13791
K830541 · Quinton, Inc. · Aug 1983
WINGED CATHETER
K830765 · Abbott Laboratories · Mar 1983
WHOLEY OCCLUSION BALLOON CATHETER
K772011 · Cook, Inc. · Jun 1979
I.V. START KIT
K780350 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1978
NEEDLE CONNECTING SET, BLUNT
K780105 · Abbott Laboratories · Feb 1978