Cleared Traditional

K915804 - PROPPER LARYNGOSCOPE BLADES W FIBER OPT...

K915804 is an FDA 510(k) clearance for PROPPER LARYNGOSCOPE BLADES W FIBER OPT..., manufactured by Propper Mfg. Co., Inc.. The device is a Class 1 Anesthesiology device with product code CCW cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K915804 · Propper Mfg. Co., Inc. · Anesthesiology device
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Mar 1992
Decision
87d
Days
Class 1
Risk

K915804 is an FDA 510(k) clearance for the PROPPER LARYNGOSCOPE BLADES W FIBER OPTIC ILLUM.. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Propper Mfg. Co., Inc. (Long Island City, US). The FDA issued a Cleared decision on March 20, 1992 after a review of 87 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 Propper Mfg. Co., Inc. devices

FDA 510(k) Submission Details - K915804

510(k) Number K915804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1991
Decision Date March 20, 1992
Days to Decision 87 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
53d faster than avg
Panel avg: 140d · This submission: 87d
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 14
Devices cleared under the same product code (CCW) and FDA review panel - the closest regulatory comparables to K915804.
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K882930 · Pilling Co. · Aug 1988
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K882659 · Augustine Medical, Inc. · Jul 1988