Cleared Traditional

K780510 - NUCLEAR STETHOSCOPE (FDA 510(k) Clearance)

Class I Radiology device.

K780510 · Bios, Inc. · Radiology device
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Apr 1978
Decision
19d
Days
Class 1
Risk

K780510 is an FDA 510(k) clearance for the NUCLEAR STETHOSCOPE. Classified as Synchronizer, Electrocardiograph, Nuclear (product code IYY), Class I - General Controls.

Submitted by Bios, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 18, 1978 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1410 - the FDA radiology and imaging software 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 Bios, Inc. devices

Submission Details

510(k) Number K780510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1978
Decision Date April 18, 1978
Days to Decision 19 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 107d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYY Synchronizer, Electrocardiograph, Nuclear
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1410
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.