Cleared Traditional

ANEROID BLOOD PRESSURE GAUGE (K904376) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K904376 · Biomedical Dynamics, Inc. · Gastroenterology & Urology device
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Dec 1990
Decision
86d
Days
Class 1
Risk

K904376 is an FDA 510(k) clearance for the ANEROID BLOOD PRESSURE GAUGE. Classified as Bulb, Inflation, For Endoscope (product code FCY), Class I - General Controls.

Submitted by Biomedical Dynamics, Inc. (Burnsville, US). The FDA issued a Cleared decision on December 20, 1990 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device 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 Biomedical Dynamics, Inc. devices

Submission Details

510(k) Number K904376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1990
Decision Date December 20, 1990
Days to Decision 86 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 130d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FCY Bulb, Inflation, For Endoscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1500
Definition An Endoscope Bulb Pressurizes The Interior Of An Endoscope. The User Identifies The Presence Of Leaks In The Endoscope By Immersing In Water And Visually Observing For Bubbles.
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.