Cleared Traditional

K811862 - HI-LO TEMP ESOPHAGEAL STETHOSCOPE (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K811862 · Mallinckrodt Critical Care · Anesthesiology device
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Jul 1981
Decision
9d
Days
Class 2
Risk

K811862 is an FDA 510(k) clearance for the HI-LO TEMP ESOPHAGEAL STETHOSCOPE. Classified as Stethoscope, Esophageal, With Electrical Conductors (product code BZT), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981 after a review of 9 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 Mallinckrodt Critical Care devices

Submission Details

510(k) Number K811862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1981
Decision Date July 10, 1981
Days to Decision 9 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: 139d · This submission: 9d
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.