Cleared Traditional

K844310 - BLOOD-PRESSURE ECG TRANSMITTER

K844310 is the FDA 510(k) clearance for BLOOD-PRESSURE ECG TRANSMITTER by Instromedix, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K844310 · Instromedix, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
163d
Days
Class 2
Risk

K844310 is an FDA 510(k) clearance for the BLOOD-PRESSURE ECG TRANSMITTER. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Instromedix, Inc. (Beaverton, US). The FDA issued a Cleared decision on April 18, 1985 after a review of 163 days - an extended review cycle.

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 Instromedix, Inc. devices

Submission Details

510(k) Number K844310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1984
Decision Date April 18, 1985
Days to Decision 163 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 125d · This submission: 163d
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 529
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K844310.
WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C
K852574 · Welch Allyn, Inc. · Mar 1986
MODEL 9300 TREND ANALYZING BIO-MONITOR SYS
K844252 · Medtronic Vascular · Jun 1985
ACCU-TRAC
K843055 · Olympic Medical Corp. · May 1985
PHYSIOLOGICAL MONITOR 2100
K844353 · Datascope Corp. · Apr 1985
DINAMAP VITAL SIGNS MONITOR 1846 SX & 1846P SX
K844839 · Critikon Company, LLC · Apr 1985
ACCUTORR CSM SYSTEM
K842538 · Datascope Corp. · Mar 1985