Cleared Traditional

K884742 - ESCORT NON-INVASIVE BLOOD PRESSURE OPTION

K884742 is an FDA 510(k) clearance for ESCORT NON-INVASIVE BLOOD PRESSURE OPTION, manufactured by Medical Data Electronics. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K884742 · Medical Data Electronics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1989
Decision
80d
Days
Class 2
Risk

K884742 is an FDA 510(k) clearance for the ESCORT NON-INVASIVE BLOOD PRESSURE OPTION. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on February 2, 1989 after a review of 80 days - a notably fast clearance 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: 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 Data Electronics devices

FDA 510(k) Submission Details - K884742

510(k) Number K884742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1988
Decision Date February 02, 1989
Days to Decision 80 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
45d faster than avg
Panel avg: 125d · This submission: 80d
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 565
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K884742.
NON-INVASIVE BLOOD PRESSURE MODULE
K894945 · Marquette Electronics, Inc. · Oct 1989
AP-851PA NIBP MODULE
K894693 · Nihon Kohden America, Inc. · Oct 1989
TYPE 9225 NIBP
K890005 · S & W Medico Teknik · May 1989
TAKEDA MEDICAL AUTO. DIGITAL BLOOD PRES. MONITOR
K882824 · A&D Engineering, Inc. · Jan 1989
TAKEDA MEDICAL AUTO. DIG. BLOOD PRES. METER W/PRIN
K882825 · A&D Engineering, Inc. · Jan 1989
CARDIOCAP(TM) CM-104 MONITOR
K884955 · Datex Division Instrumentarium Corp. · Dec 1988