Cleared Traditional

K882659 - AUGUSTINE INTUBATION GUIDE(TM)

K882659 is an FDA 510(k) clearance for AUGUSTINE INTUBATION GUIDE(TM), manufactured by Augustine Medical, Inc.. The device is a Class 1 Anesthesiology device with product code CCW cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K882659 · Augustine Medical, Inc. · Anesthesiology device
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Jul 1988
Decision
23d
Days
Class 1
Risk

K882659 is an FDA 510(k) clearance for the AUGUSTINE INTUBATION GUIDE(TM). Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Augustine Medical, Inc. (Blue Springs, US). The FDA issued a Cleared decision on July 21, 1988 after a review of 23 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 Augustine Medical, Inc. devices

FDA 510(k) Submission Details - K882659

510(k) Number K882659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1988
Decision Date July 21, 1988
Days to Decision 23 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 140d · This submission: 23d
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 K882659.
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
LARYNGOSCOPE BLADES/HANDLES & LAMPS
K833055 · Medovations, Inc. · Nov 1983
FIBER OPTIC LARYNGOSCOPES W/BATTERY
K830047 · Welch Allyn, Inc. · Jan 1983
OROTRACHEAL INTUBATION ENDOSCOPE
K801452 · Olympus Corp. · Jul 1980