Cleared Traditional

K944729 - STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE

K944729 is an FDA 510(k) clearance for STYLET SHEATH WITH LOCKING CAP AND REUS..., manufactured by Coast Medical, Inc.. The device is a Class 1 Anesthesiology device with product code BSR cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K944729 · Coast Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
86d
Days
Class 1
Risk

K944729 is an FDA 510(k) clearance for the STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE. Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Coast Medical, Inc. (Orange, US). The FDA issued a Cleared decision on December 21, 1994 after a review of 86 days - a notably fast clearance cycle.

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: 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 Coast Medical, Inc. devices

FDA 510(k) Submission Details - K944729

510(k) Number K944729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1994
Decision Date December 21, 1994
Days to Decision 86 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 140d · This submission: 86d
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 18
Devices cleared under the same product code (BSR) and FDA review panel - the closest regulatory comparables to K944729.
RUSCH ENDOTRACHEAL TUBE STYLET
K952100 · Rusch, Inc. · Aug 1995
AIRGUIDE STYLETTE
K950713 · Polamedco, Inc. · May 1995
FLEXTITIP STYLETTE
K950380 · Polamedco, Inc. · Feb 1995
AUGUSTINE STYLET
K920468 · Augustine Medical, Inc. · Apr 1992
AUGUSTINE GUIDE(TM) KIT
K912690 · Augustine Medical, Inc. · Sep 1991
AUGUSTINE STYLET
K910659 · Augustine Medical, Inc. · May 1991