Cleared Traditional

K771393 - ELHCTRONIC SPHYGMOMANOMETER

K771393 is an FDA 510(k) clearance for ELHCTRONIC SPHYGMOMANOMETER, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K771393 · C.R. Bard, Inc. · Cardiovascular device
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Nov 1977
Decision
106d
Days
Class 2
Risk

K771393 is an FDA 510(k) clearance for the ELHCTRONIC SPHYGMOMANOMETER. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Warrendale, US). The FDA issued a Cleared decision on November 11, 1977 after a review of 106 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

FDA 510(k) Submission Details - K771393

510(k) Number K771393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1977
Decision Date November 11, 1977
Days to Decision 106 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
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

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 845
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K771393.
TREND II ANEROID
K780598 · Abco Dealers, Inc. · Jun 1978
ACCES. ANALOG OUTPUT ADAPTOR MODEL 910
K780358 · Applied Medical Research · Apr 1978
ULTRASPHYG BLOOD PRESSURE OPTION
K780046 · Cavitron Corp. · Mar 1978
ELECTRONIC STETHESCOPE
K771394 · C.R. Bard, Inc. · Nov 1977
MONITOR, DINMAP, MODEL 850
K771931 · Applied Medical Research · Oct 1977
DINAMAP MADEL 845
K771895 · Applied Medical Research · Oct 1977