Cleared Traditional

K840909 - AUTOMATED NON-INVASIVE PRESSURE MODULE

K840909 is the FDA 510(k) clearance for AUTOMATED NON-INVASIVE PRESSURE MODULE by Gould, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K840909 · Gould, Inc. · Cardiovascular device
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Jun 1984
Decision
107d
Days
Class 2
Risk

K840909 is an FDA 510(k) clearance for the AUTOMATED NON-INVASIVE PRESSURE MODULE. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Gould, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1984 after a review of 107 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 Gould, Inc. devices

Submission Details

510(k) Number K840909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 1984
Decision Date June 15, 1984
Days to Decision 107 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 125d · This submission: 107d
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 389
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K840909.
ACCUTORR CSM SYSTEM
K842538 · Datascope Corp. · Mar 1985
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K840932 · Marquette Electronics, Inc. · Oct 1984
NON-INVASIVE BP MODULE 7000
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DRAGER SPHYGMOMED
K840162 · Draeger Medical, Inc. · May 1984
VERIFORM II
K833583 · American Medical Systems, Inc. · Jan 1984
LIFESTAT 200
K831232 · Physio-Control Corp. · Jul 1983