Cleared Traditional

A.P.GRAPH III(TM) CARDIOVASCULAR ANALYZER (K905114) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K905114 · Research Consultants, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1991
Decision
175d
Days
Class 2
Risk

K905114 is an FDA 510(k) clearance for the A.P.GRAPH III(TM) CARDIOVASCULAR ANALYZER. Classified as Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (product code JOM), Class II - Special Controls.

Submitted by Research Consultants, Inc. (Mendham, US). The FDA issued a Cleared decision on May 7, 1991 after a review of 175 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2780 - 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 Research Consultants, Inc. devices

Submission Details

510(k) Number K905114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1990
Decision Date May 07, 1991
Days to Decision 175 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 125d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2780
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 - JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

Devices cleared under the same product code (JOM) and FDA review panel - the closest regulatory comparables to K905114.
Automated ankle brachial pressure index measuring device, MESI mTABLET system
K201046 · Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. · Dec 2020
VitalScan ANS
K191266 · Medeia, Inc. · Jan 2020
Automated ankle brachial pressure index measuring device
K172655 · Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. · Jan 2018