Cleared Traditional

PLETHYSMOGRAPH (MDI SYSTEM II) (K760504) - FDA 510(k) Clearance

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

K760504 · Marketing Development Intl. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1976
Decision
3d
Days
Class 2
Risk

K760504 is an FDA 510(k) clearance for the PLETHYSMOGRAPH (MDI SYSTEM II). Classified as Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (product code JOM), Class II - Special Controls.

Submitted by Marketing Development Intl. (Mchenry, US). The FDA issued a Cleared decision on August 26, 1976 after a review of 3 days - a notably fast clearance 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: 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 Marketing Development Intl. devices

Submission Details

510(k) Number K760504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1976
Decision Date August 26, 1976
Days to Decision 3 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 125d · This submission: 3d
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 K760504.
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