Cleared Traditional

K910659 - AUGUSTINE STYLET

K910659 is an FDA 510(k) clearance for AUGUSTINE STYLET, manufactured by Augustine Medical, Inc.. The device is a Class 1 Anesthesiology device with product code BSR cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K910659 · Augustine Medical, Inc. · Anesthesiology device
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May 1991
Decision
92d
Days
Class 1
Risk

K910659 is an FDA 510(k) clearance for the AUGUSTINE STYLET. Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Augustine Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on May 17, 1991 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5790 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Augustine Medical, Inc. devices

FDA 510(k) Submission Details - K910659

510(k) Number K910659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1991
Decision Date May 17, 1991
Days to Decision 92 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
48d faster than avg
Panel avg: 140d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

BSR Device Classification - Class 1, General Controls

Product Code BSR Stylet, Tracheal Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5790
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 - BSR Stylet, Tracheal Tube

All 12
Devices cleared under the same product code (BSR) and FDA review panel - the closest regulatory comparables to K910659.
RUSCH ENDOTRACHEAL TUBE STYLET
K952100 · Rusch, Inc. · Aug 1995
AUGUSTINE STYLET
K920468 · Augustine Medical, Inc. · Apr 1992
AUGUSTINE GUIDE(TM) KIT
K912690 · Augustine Medical, Inc. · Sep 1991
STYLET TRACHAEL TUBE
K905133 · Medical Devices, Inc. · Apr 1991
BIVONA ENDOTRACHEAL TUBE STYLET
K905052 · Bivona Medical Technologies · Apr 1991
N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE
K865108 · Ackrad Laboratories · Feb 1987