Cleared Traditional

K771394 - ELECTRONIC STETHESCOPE

K771394 is the FDA 510(k) clearance for ELECTRONIC STETHESCOPE by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K771394 · C.R. Bard, Inc. · Cardiovascular device
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Nov 1977
Decision
104d
Days
Class 2
Risk

K771394 is an FDA 510(k) clearance for the ELECTRONIC STETHESCOPE. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 9, 1977 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K771394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1977
Decision Date November 09, 1977
Days to Decision 104 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 125d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 516
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K771394.
PRESSURE INFUSION CUFF
K781556 · Abbott Laboratories · Oct 1978
TREND II ANEROID
K780598 · Abco Dealers, Inc. · Jun 1978
ELHCTRONIC SPHYGMOMANOMETER
K771393 · C.R. Bard, Inc. · Nov 1977
PRESSUROMETER II
K771500 · Del Mar Avionics · Aug 1977
ELECTRONIC BLOOD PRESSURE UNIT
K761302 · Medline Industries, Inc. · Jan 1977