Cleared Traditional

K953793 - INTROSCOPE

K953793 is an FDA 510(k) clearance for INTROSCOPE, manufactured by Polamedco, Inc.. The device is a Class 2 Anesthesiology device with product code BZT cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K953793 · Polamedco, Inc. · Anesthesiology device
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Nov 1995
Decision
107d
Days
Class 2
Risk

K953793 is an FDA 510(k) clearance for the INTROSCOPE. Classified as Stethoscope, Esophageal, With Electrical Conductors (product code BZT), Class II - Special Controls.

Submitted by Polamedco, Inc. (Marina Del Rey, US). The FDA issued a Cleared decision on November 29, 1995 after a review of 107 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Polamedco, Inc. devices

FDA 510(k) Submission Details - K953793

510(k) Number K953793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1995
Decision Date November 29, 1995
Days to Decision 107 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 140d · This submission: 107d
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 31
Devices cleared under the same product code (BZT) and FDA review panel - the closest regulatory comparables to K953793.
ESOPHAGEAL STETHOSCOPE
K982193 · Shore Medical, Inc. · Sep 1998
DISPOSABLE ESOPHAGEAL STETHOSCOPE
K973839 · Catheter Research, Inc. · Mar 1998
ARISTO ESOPHAGEAL STETHOSCOPE
K961060 · Aristo Medical Products, Inc. · Jun 1996
ESOPHAGEAL STETHOSCOPE
K930929 · Coast Medical Corp. · Mar 1995
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