Cleared Traditional

K914168 - AUGUSTINE GUIDE KIT WITH GAUZE SPONGE

K914168 is an FDA 510(k) clearance for AUGUSTINE GUIDE KIT WITH GAUZE SPONGE, 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 20-day FDA review.

K914168 · Augustine Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
20d
Days
Class 1
Risk

K914168 is an FDA 510(k) clearance for the AUGUSTINE GUIDE KIT WITH GAUZE SPONGE. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Augustine Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on October 7, 1991 after a review of 20 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 - K914168

510(k) Number K914168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1991
Decision Date October 07, 1991
Days to Decision 20 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 140d · This submission: 20d
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 K914168.
AUGUSTINE GUIDE KIT
K921166 · Augustine Medical, Inc. · Apr 1992
BAUMAN DISPOSABLE LARYNGOSCOPE BLADES
K905273 · Vital Signs, Inc. · Mar 1992
PROPPER LARYNGOSCOPE BLADES W FIBER OPTIC ILLUM.
K915804 · Propper Mfg. Co., Inc. · Mar 1992
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