Cleared Traditional

K851102 - VASOSCREEN IMPEDANCE PLETHYSMOGRAPH (FDA 510(k) Clearance)

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

K851102 · Sonicaid, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1985
Decision
58d
Days
Class 2
Risk

K851102 is an FDA 510(k) clearance for the VASOSCREEN IMPEDANCE PLETHYSMOGRAPH. Classified as Phlebograph, Impedance (product code DQB), Class II - Special Controls.

Submitted by Sonicaid, Inc. (Fredericksburg, US). The FDA issued a Cleared decision on May 16, 1985 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2750 - 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 Sonicaid, Inc. devices

Submission Details

510(k) Number K851102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1985
Decision Date May 16, 1985
Days to Decision 58 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQB Phlebograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2750
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.