Cleared Traditional

K864043 - ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE T...

K864043 is an FDA 510(k) clearance for ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE T..., manufactured by Respiratory Support Products, Inc.. The device is a Class 2 Anesthesiology device with product code BZT cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K864043 · Respiratory Support Products, Inc. · Anesthesiology device
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Dec 1986
Decision
60d
Days
Class 2
Risk

K864043 is an FDA 510(k) clearance for the ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T. Classified as Stethoscope, Esophageal, With Electrical Conductors (product code BZT), Class II - Special Controls.

Submitted by Respiratory Support Products, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on December 15, 1986 after a review of 60 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 Respiratory Support Products, Inc. devices

FDA 510(k) Submission Details - K864043

510(k) Number K864043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1986
Decision Date December 15, 1986
Days to Decision 60 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
80d faster than avg
Panel avg: 140d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZT Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (BZT) and FDA review panel - the closest regulatory comparables to K864043.
SHERIDAN ELECTROSURGERY PROTECTION FILTER
K881293 · Sheridan Catheter Corp. · Jun 1988
ESOPHAGEAL STETHOSCOPE W/ELECTRICAL CONDUCTORS
K874295 · Sheridan Catheter Corp. · Nov 1987
ESOPHAGEAL STETHOSCOPE W/THERMISTOR
K873344 · Medical Components, Inc. · Oct 1987
ESOPHAGEAL STETHOSCOPE WITH THERMISTOR
K862672 · Inmed Corp. · Oct 1986
SHERIDAN - YSI/ECG SONATEMP (TM)
K861541 · Sheridan Catheter Corp. · Jun 1986
ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR
K854212 · Respiratory Support Products, Inc. · Jan 1986