Cleared Traditional

K853099 - L.O.N. PRES MON LINES, CPC LINES, ADMINISTRATION

K853099 is an FDA 510(k) clearance for L.O.N. PRES MON LINES, 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 133-day FDA review.

K853099 · L.O.N. Research, Inc. · Cardiovascular device
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Dec 1985
Decision
133d
Days
Class 2
Risk

K853099 is an FDA 510(k) clearance for the L.O.N. PRES MON LINES, CPC LINES, ADMINISTRATION. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by L.O.N. Research, Inc. (Longwood, US). The FDA issued a Cleared decision on December 3, 1985 after a review of 133 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 - K853099

510(k) Number K853099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1985
Decision Date December 03, 1985
Days to Decision 133 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 125d · This submission: 133d
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 K853099.
HEMOSTATIC SIDEARM
K854397 · Target Therapeutics · Jan 1986
ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL
K853950 · American Bentley · Dec 1985
ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES
K854261 · Advanced Cardiovascular Systems, Inc. · Dec 1985
PRESSURE SENSING SYRINGE 65000
K853586 · Dlp, Inc. · Nov 1985
CAPIOX BLOOD SAMPLING MANIFOLD
K852086 · Terumo Medical Corp. · Aug 1985
SILENT GUARD CAT. NO. SG-30
K851465 · American Omni Medical, Inc. · Aug 1985