Cleared Traditional

K811928 - LIFESOUND ESOPHAGEAL STETHOSCOPE

K811928 is the FDA 510(k) clearance for LIFESOUND ESOPHAGEAL STETHOSCOPE by Biomedical Concepts, Inc.. It is a Class 2 Anesthesiology device (product code BZT) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K811928 · Biomedical Concepts, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1981
Decision
22d
Days
Class 2
Risk

K811928 is an FDA 510(k) clearance for the LIFESOUND ESOPHAGEAL STETHOSCOPE. Classified as Stethoscope, Esophageal, With Electrical Conductors (product code BZT), Class II - Special Controls.

Submitted by Biomedical Concepts, Inc. (Walker, US). The FDA issued a Cleared decision on July 28, 1981 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1920 - the FDA anesthesiology and respiratory 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 Concepts, Inc. devices

Submission Details

510(k) Number K811928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1981
Decision Date July 28, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 140d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZT Stethoscope, Esophageal, With Electrical Conductors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1920
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 Anesthesiology devices follow this clearance model.