Cleared Traditional

K883414 - LARYNGOSCOPE BLADES

K883414 is an FDA 510(k) clearance for LARYNGOSCOPE BLADES, manufactured by Truphatek, Ltd.. The device is a Class 1 Anesthesiology device with product code CCW cleared through the Traditional 510(k) pathway after a 4-day FDA review.

K883414 · Truphatek, Ltd. · Anesthesiology device
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Aug 1988
Decision
4d
Days
Class 1
Risk

K883414 is an FDA 510(k) clearance for the LARYNGOSCOPE BLADES. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Truphatek, Ltd. (Netanya, IL). The FDA issued a Cleared decision on August 19, 1988 after a review of 4 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, Ltd. devices

FDA 510(k) Submission Details - K883414

510(k) Number K883414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1988
Decision Date August 19, 1988
Days to Decision 4 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d faster than avg
Panel avg: 140d · This submission: 4d
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 K883414.
BAUMAN DISPOSABLE LARYNGOSCOPE BLADES
K905273 · Vital Signs, Inc. · Mar 1992
PROPPER LARYNGOSCOPE BLADES W FIBER OPTIC ILLUM.
K915804 · Propper Mfg. Co., Inc. · Mar 1992
AUGUSTINE GUIDE KIT WITH GAUZE SPONGE
K914168 · Augustine Medical, Inc. · Oct 1991
LASER LARYNGOSCOPE DEDO ARTICULA. & FEDER DEDO EX
K882930 · Pilling Co. · Aug 1988
AUGUSTINE INTUBATION GUIDE(TM)
K882659 · Augustine Medical, Inc. · Jul 1988
LARYNGOSCOPE BLADES/HANDLES & LAMPS
K833055 · Medovations, Inc. · Nov 1983