Cleared Traditional

K896958 - ESCORT NON-INVASIVE BLOOD PRESSURE OPTION

K896958 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 89-day FDA review.

K896958 · Medical Data Electronics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
89d
Days
Class 2
Risk

K896958 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 March 13, 1990 after a review of 89 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 - K896958

510(k) Number K896958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1989
Decision Date March 13, 1990
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
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 K896958.
LOCAL REPORT GENERATOR
K904318 · Spacelabs, Inc. · Dec 1990
BIOCHEM 6100 NON-INVASIVE MONITOR
K903222 · Biochem International, Inc. · Sep 1990
FUKUDA DENSHI MODEL HJ-310
K901889 · Fukuda Denshi USA, Inc. · Jul 1990
SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283
K882955 · Kontron Instruments, Inc. · Jan 1990
A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2510/20
K895428 · A&D Engineering, Inc. · Nov 1989
A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2650
K895429 · A&D Engineering, Inc. · Nov 1989