Cleared Traditional

PALPATION ENHANCER (K801811) - FDA 510(k) Clearance

Class I Cardiovascular device.

K801811 · Medical Horizons Co. · Cardiovascular device
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Sep 1980
Decision
63d
Days
Class 1
Risk

K801811 is an FDA 510(k) clearance for the PALPATION ENHANCER. Classified as Stethoscope, Manual (product code LDE), Class I - General Controls.

Submitted by Medical Horizons Co. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1980 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - 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 Medical Horizons Co. devices

Submission Details

510(k) Number K801811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1980
Decision Date September 09, 1980
Days to Decision 63 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDE Stethoscope, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.1875
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LDE Stethoscope, Manual

Devices cleared under the same product code (LDE) and FDA review panel - the closest regulatory comparables to K801811.
LITTMAN TUNABLE STETHOSCOPE 2136
K821909 · 3M Company · Jul 1982
CONPHAR DUAL HEAD STETHOSCOPE
K801183 · Conphar, Inc. · Jun 1980
CONPHAR SPRAGUE RAPPAPORT STETHOSCOPE
K801184 · Conphar, Inc. · Jun 1980
CONPHAR BOWLS STETHOSCOPE
K801185 · Conphar, Inc. · Jun 1980
ABCO PEDIATRIC STETHOSCOPE
K801215 · Abco Dealers, Inc. · Jun 1980