Cleared Traditional

K833155 - RAYDEN MEDICAL MINI PULSE VOLUME RECORD (FDA 510(k) Clearance)

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

K833155 · Burditt & Calkins-Siemens-Elema · Cardiovascular device
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Jan 1984
Decision
133d
Days
Class 2
Risk

K833155 is an FDA 510(k) clearance for the RAYDEN MEDICAL MINI PULSE VOLUME RECORD. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Burditt & Calkins-Siemens-Elema (Walker, US). The FDA issued a Cleared decision on January 26, 1984 after a review of 133 days - within the typical 510(k) review window.

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 Burditt & Calkins-Siemens-Elema devices

Submission Details

510(k) Number K833155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1983
Decision Date January 26, 1984
Days to Decision 133 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 125d · This submission: 133d
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.

Regulatory Peers - DSB Plethysmograph, Impedance

All 113
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