Cleared Traditional

K841574 - QUAZAR ESOPHAGEAL STETHOSCOPE

K841574 is an FDA 510(k) clearance for QUAZAR ESOPHAGEAL STETHOSCOPE, manufactured by Axiom Medical, Inc.. The device is a Class 1 Anesthesiology device with product code BZW cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K841574 · Axiom Medical, Inc. · Anesthesiology device
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Aug 1984
Decision
120d
Days
Class 1
Risk

K841574 is an FDA 510(k) clearance for the QUAZAR ESOPHAGEAL STETHOSCOPE. Classified as Stethoscope, Esophageal (product code BZW), Class I - General Controls.

Submitted by Axiom Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 15, 1984 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1910 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Axiom Medical, Inc. devices

FDA 510(k) Submission Details - K841574

510(k) Number K841574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1984
Decision Date August 15, 1984
Days to Decision 120 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 140d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

BZW Device Classification - Class 1, General Controls

Product Code BZW Stethoscope, Esophageal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.1910
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.

Regulatory Peers - BZW Stethoscope, Esophageal

Devices cleared under the same product code (BZW) and FDA review panel - the closest regulatory comparables to K841574.
ESOPHAGEAL STETHOSCOPE
K842865 · Inmed Corp. · Aug 1984
SHERIDAN/ESOPHAGEAL STETHOSCOPE
K830218 · Sheridan Catheter Corp. · Mar 1983
MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER
K823126 · Electromedics, Inc. · Nov 1982
ESOPHAGEAL STETHESCOPE
K800463 · Medical Components, Inc. · Mar 1980
ARGYLE ESOPHAGEAL STETHOSCOPE
K790523 · Sherwood Medical Industries · Mar 1979