Cleared Traditional

K812408 - L.O.N. DISPOSABLE CORONARY MANIFOLD

K812408 is an FDA 510(k) clearance for L.O.N. DISPOSABLE CORONARY MANIFOLD, manufactured by L.O.N. Research, Inc.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K812408 · L.O.N. Research, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K812408

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.

DTL Device Classification - Class 2, Special Controls

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 109
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K812408.
SCI MED TUBING CONNECTORS
K831261 · Scimed Life Systems, Inc. · Jun 1983
NORTON MANIFOLD
K820864 · Norton Performance Plastics Corp. · Apr 1982
WM. HARVEY OVERPRESSURE SAFETY VALVE
K820297 · C.R. Bard, Inc. · Mar 1982
VYGON STOPCOCKS & RAMPS(MANIFOLDS)
K813141 · Exco, Inc. · Nov 1981
DISPOSABLE QUICK RELEASE PERFUSION ADAP
K802544 · Texas Medical Products, Inc. · Jan 1981
MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS
K801828 · Graphic Controls Corp. · Aug 1980