Cleared Traditional

K926158 - SLATER SLEEVE

K926158 is an FDA 510(k) clearance for SLATER SLEEVE, manufactured by Tadco, Inc.. The device is a Class 1 Anesthesiology device with product code CCW cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K926158 · Tadco, Inc. · Anesthesiology device
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Mar 1993
Decision
101d
Days
Class 1
Risk

K926158 is an FDA 510(k) clearance for the SLATER SLEEVE. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Tadco, Inc. (Stamford, US). The FDA issued a Cleared decision on March 19, 1993 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5540 - 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 Tadco, Inc. devices

FDA 510(k) Submission Details - K926158

510(k) Number K926158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1992
Decision Date March 19, 1993
Days to Decision 101 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 140d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

CCW Device Classification - Class 1, General Controls

Product Code CCW Laryngoscope, Rigid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CCW Laryngoscope, Rigid

All 29
Devices cleared under the same product code (CCW) and FDA review panel - the closest regulatory comparables to K926158.
AUGUSTINE INTUBATION GUIDE
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AUGUSTINE FIBEROPTIC LARYNGOSCOPE
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