Cleared Traditional

K911194 - IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRA...

K911194 is the FDA 510(k) clearance for IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRA... by Rjl Systems, Inc.. It is a Class 2 Cardiovascular device (product code DSB) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K911194 · Rjl Systems, Inc. · Cardiovascular device
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Sep 1991
Decision
196d
Days
Class 2
Risk

K911194 is an FDA 510(k) clearance for the IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Rjl Systems, Inc. (Clinton Twp, US). The FDA issued a Cleared decision on September 30, 1991 after a review of 196 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - 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 Rjl Systems, Inc. devices

Submission Details

510(k) Number K911194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1991
Decision Date September 30, 1991
Days to Decision 196 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 125d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
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.