Cleared Traditional

K801200 - SAMPLING MANIFOLD H530

K801200 is the FDA 510(k) clearance for SAMPLING MANIFOLD H530 by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DTL) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K801200 · C.R. Bard, Inc. · Cardiovascular device
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Jun 1980
Decision
16d
Days
Class 2
Risk

K801200 is an FDA 510(k) clearance for the SAMPLING MANIFOLD H530. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 4, 1980 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - the FDA cardiovascular device oversight 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K801200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1980
Decision Date June 04, 1980
Days to Decision 16 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 65
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K801200.
NORTON MANIFOLD
K820864 · Norton Performance Plastics Corp. · Apr 1982
WM. HARVEY OVERPRESSURE SAFETY VALVE
K820297 · C.R. Bard, Inc. · Mar 1982
MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS
K801828 · Graphic Controls Corp. · Aug 1980
CONPHAR MANOMETER CONNECTORS
K792113 · Conphar, Inc. · Dec 1979
3-WAY STOPCOCK W/MALE LOCKING LUER ADA.
K791914 · Abbott Laboratories · Oct 1979
ADAPTER-Y TYPE/CORONARY PERFUSION
K791498 · Dlp, Inc. · Aug 1979