Cleared Traditional

K854212 - ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/T...

K854212 is an FDA 510(k) clearance for ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/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 78-day FDA review.

K854212 · Respiratory Support Products, Inc. · Anesthesiology device
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Jan 1986
Decision
78d
Days
Class 2
Risk

K854212 is an FDA 510(k) clearance for the ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR. 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 January 3, 1986 after a review of 78 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 - K854212

510(k) Number K854212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1985
Decision Date January 03, 1986
Days to Decision 78 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
62d faster than avg
Panel avg: 140d · This submission: 78d
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 K854212.
ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T
K864043 · Respiratory Support Products, Inc. · Dec 1986
ESOPHAGEAL STETHOSCOPE WITH THERMISTOR
K862672 · Inmed Corp. · Oct 1986
SHERIDAN - YSI/ECG SONATEMP (TM)
K861541 · Sheridan Catheter Corp. · Jun 1986
SHERIDAN YSI/SONATEMP
K841098 · Sheridan Catheter Corp. · Apr 1984
CARDIO-ESOPHASCOPE
K830716 · Portex, Inc. · Aug 1983
MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO
K823743 · Y · Jan 1983