Cleared Traditional

K964235 - ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL

K964235 is an FDA 510(k) clearance for ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, manufactured by Industrielle Entwicklung Medizintechnik Und Vertri. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 860-day FDA review.

K964235 · Industrielle Entwicklung Medizintechnik Und Vertri · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
860d
Days
Class 2
Risk

K964235 is an FDA 510(k) clearance for the ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Industrielle Entwicklung Medizintechnik Und Vertri (Stamford, US). The FDA issued a Cleared decision on March 2, 1999 after a review of 860 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Industrielle Entwicklung Medizintechnik Und Vertri devices

FDA 510(k) Submission Details - K964235

510(k) Number K964235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1996
Decision Date March 02, 1999
Days to Decision 860 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
735d slower than avg
Panel avg: 125d · This submission: 860d
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 K964235.
AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL NUMBER WS-300
K981702 · Nihon Seimitsu Sokki Co., Ltd. · Mar 1999
PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW280
K981431 · Panasonic Corporation (Panasonic) · Mar 1999
PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW284
K981542 · Panasonic Corporation (Panasonic) · Mar 1999
(1) DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-250
K990380 · Meditec Co., Ltd. · Feb 1999
6004 NIBP MONITOR WITH TEMPERATURE
K983796 · Bci Intl., Inc. · Jan 1999
MS-900S, MS-900SPM & MS-900SFM
K980845 · Mars Medical Products · Dec 1998