Cleared Traditional

K840169 - PHONOANGIOGRAPHIC SPECTRAL ANALYZER

K840169 is the FDA 510(k) clearance for PHONOANGIOGRAPHIC SPECTRAL ANALYZER by Biotronics Instruments. It is a Class 2 Cardiovascular device (product code DPW) cleared through the Traditional 510(k) pathway after a 410-day FDA review.

K840169 · Biotronics Instruments · Cardiovascular device
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Mar 1985
Decision
410d
Days
Class 2
Risk

K840169 is an FDA 510(k) clearance for the PHONOANGIOGRAPHIC SPECTRAL ANALYZER. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Biotronics Instruments (Wauwatosa, US). The FDA issued a Cleared decision on March 1, 1985 after a review of 410 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Biotronics Instruments devices

Submission Details

510(k) Number K840169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1984
Decision Date March 01, 1985
Days to Decision 410 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
285d slower than avg
Panel avg: 125d · This submission: 410d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
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 - DPW Flowmeter, Blood, Cardiovascular

All 34
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K840169.
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K820742 · Nihon Kohden America, Inc. · Apr 1982