Cleared Traditional

MANIFOLD CLAMPS (K852118) - FDA 510(k) Clearance

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

K852118 · Omser Sv., Inc. · Cardiovascular device
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Jun 1985
Decision
22d
Days
Class 2
Risk

K852118 is an FDA 510(k) clearance for the MANIFOLD CLAMPS. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Omser Sv., Inc. (Colubmus, US). The FDA issued a Cleared decision on June 6, 1985 after a review of 22 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 Omser Sv., Inc. devices

Submission Details

510(k) Number K852118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1985
Decision Date June 06, 1985
Days to Decision 22 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 125d · This submission: 22d
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 27
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K852118.
LUER LOCK SKIRT
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CAPIOX BLOOD SAMPLING MANIFOLD
K852086 · Terumo Medical Corp. · Aug 1985
ARTERIAL FILTER PURGE LINE W/CHECK VALV
K840603 · Shiley, Inc. · Apr 1984
WM. HARVEY OVERPRESSURE SAFETY VALVE
K820297 · C.R. Bard, Inc. · Mar 1982
SAMPLING MANIFOLD H530
K801200 · C.R. Bard, Inc. · Jun 1980