Cleared Traditional

K062523 - TRU-MR LARYNGOSCOPE SET

K062523 is an FDA 510(k) clearance for TRU-MR LARYNGOSCOPE SET, manufactured by Truphatek International, Ltd.. The device is a Class 1 Anesthesiology device with product code CCW cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K062523 · Truphatek International, Ltd. · Anesthesiology device
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Nov 2006
Decision
81d
Days
Class 1
Risk

K062523 is an FDA 510(k) clearance for the TRU-MR LARYNGOSCOPE SET. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Truphatek International, Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on November 17, 2006 after a review of 81 days - a notably fast clearance cycle.

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: 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 Truphatek International, Ltd. devices

FDA 510(k) Submission Details - K062523

510(k) Number K062523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2006
Decision Date November 17, 2006
Days to Decision 81 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
59d faster than avg
Panel avg: 140d · This submission: 81d
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 15
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