Cleared Traditional

QUANTASCOPE (K870442) - FDA 510(k) Clearance

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

K870442 · Vital Science Corp. · Cardiovascular device
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Aug 1987
Decision
189d
Days
Class 2
Risk

K870442 is an FDA 510(k) clearance for the QUANTASCOPE. Classified as Ballistocardiograph (product code DXR), Class II - Special Controls.

Submitted by Vital Science Corp. (Englewood, US). The FDA issued a Cleared decision on August 11, 1987 after a review of 189 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2320 - 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 Vital Science Corp. devices

Submission Details

510(k) Number K870442 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 03, 1987
Decision Date August 11, 1987
Days to Decision 189 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 125d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXR Ballistocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2320
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.