Cleared Traditional

K861541 - SHERIDAN - YSI/ECG SONATEMP (TM)

K861541 is the FDA 510(k) clearance for SHERIDAN - YSI/ECG SONATEMP (TM) by Sheridan Catheter Corp.. It is a Class 2 Anesthesiology device (product code BZT) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K861541 · Sheridan Catheter Corp. · Anesthesiology device
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Jun 1986
Decision
53d
Days
Class 2
Risk

K861541 is an FDA 510(k) clearance for the SHERIDAN - YSI/ECG SONATEMP (TM). Classified as Stethoscope, Esophageal, With Electrical Conductors (product code BZT), Class II - Special Controls.

Submitted by Sheridan Catheter Corp. (Argyle, US). The FDA issued a Cleared decision on June 16, 1986 after a review of 53 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 Sheridan Catheter Corp. devices

Submission Details

510(k) Number K861541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1986
Decision Date June 16, 1986
Days to Decision 53 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 140d · This submission: 53d
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.

Regulatory Peers - BZT Stethoscope, Esophageal, With Electrical Conductors

All 8
Devices cleared under the same product code (BZT) and FDA review panel - the closest regulatory comparables to K861541.
DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE
K940169 · Deroyal Industries, Inc. · Jul 1994
DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE
K925789 · Deroyal Industries, Inc. · Jul 1993
TELEMETRIC STETHOSCOPE
K882319 · Vital Signs, Inc. · Aug 1988
MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO
K823743 · Y · Jan 1983
ARGYLE ACC-U-THERM W/TEMPERATURE PROBE
K812976 · Sherwood Medical Co. · Dec 1981
HI-LO TEMP ESOPHAGEAL STETHOSCOPE
K811862 · Mallinckrodt Critical Care · Jul 1981