Cleared Traditional

K791190 - STETHOSCOPE WITH TEMPERATURE SENSOR

K791190 is the FDA 510(k) clearance for STETHOSCOPE WITH TEMPERATURE SENSOR by National Catheter Co. Div. Mallinckrodt. It is a Class 2 Anesthesiology device (product code BZT) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K791190 · National Catheter Co. Div. Mallinckrodt · Anesthesiology device
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Jul 1979
Decision
10d
Days
Class 2
Risk

K791190 is an FDA 510(k) clearance for the STETHOSCOPE WITH TEMPERATURE SENSOR. Classified as Stethoscope, Esophageal, With Electrical Conductors (product code BZT), Class II - Special Controls.

Submitted by National Catheter Co. Div. Mallinckrodt (Mchenry, US). The FDA issued a Cleared decision on July 6, 1979 after a review of 10 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 National Catheter Co. Div. Mallinckrodt devices

Submission Details

510(k) Number K791190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1979
Decision Date July 06, 1979
Days to Decision 10 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 140d · This submission: 10d
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.