Cleared Traditional

K962098 - ESOPHAGEAL INTUBATION DETECTOR

K962098 is the FDA 510(k) clearance for ESOPHAGEAL INTUBATION DETECTOR by Kirk Specialty Systems. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K962098 · Kirk Specialty Systems · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
132d
Days
Class 2
Risk

K962098 is an FDA 510(k) clearance for the ESOPHAGEAL INTUBATION DETECTOR. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Kirk Specialty Systems (Carrollton, US). The FDA issued a Cleared decision on October 8, 1996 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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 Kirk Specialty Systems devices

Submission Details

510(k) Number K962098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1996
Decision Date October 08, 1996
Days to Decision 132 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 140d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
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 - BTR Tube, Tracheal (w/wo Connector)

All 60
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K962098.
BARD ENDOTRACHEAL TUBE, CUFFED
K030792 · C.R. Bard, Inc. · Nov 2003
MODIFICATION TO LASER-SHIELD II
K993582 · Xomed, Inc. · Jan 2000
T-WALL UNCUFFED TRACHEAL TUBE
K970196 · Vital Signs, Inc. · Aug 1997
GENERAL ANESTHESIA SYSTEM
K945455 · Vital Signs, Inc. · Dec 1994
MECONIUM SUCTION DEVICE (MSD)
K914370 · Vital Signs, Inc. · Jan 1993
ENDOTRACHEAL CPAP SET
K915277 · Vital Signs, Inc. · Mar 1992