Cleared Traditional

L.O.N. DISPOSABLE CORONARY MANIFOLD (K812408) - FDA 510(k) Clearance

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

K812408 · L.O.N. Research, Inc. · Cardiovascular device
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Dec 1981
Decision
103d
Days
Class 2
Risk

K812408 is an FDA 510(k) clearance for the L.O.N. DISPOSABLE CORONARY MANIFOLD. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by L.O.N. Research, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 2, 1981 after a review of 103 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all L.O.N. Research, Inc. devices

Submission Details

510(k) Number K812408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1981
Decision Date December 02, 1981
Days to Decision 103 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 125d · This submission: 103d
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 K812408.
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
3-WAY STOPCOCK W/MALE LOCKING LUER ADA.
K791914 · Abbott Laboratories · Oct 1979
OXYGENATOR HOLDER
K780056 · C.R. Bard, Inc. · Feb 1978