Cleared Traditional

K921128 - ENDOTRACHEAL TUBE STYLET

K921128 is an FDA 510(k) clearance for ENDOTRACHEAL TUBE STYLET, manufactured by Eastmed Enterprises, Inc.. The device is a Class 1 Anesthesiology device with product code BSR cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K921128 · Eastmed Enterprises, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
84d
Days
Class 1
Risk

K921128 is an FDA 510(k) clearance for the ENDOTRACHEAL TUBE STYLET. Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Eastmed Enterprises, Inc. (Marlton, US). The FDA issued a Cleared decision on June 2, 1992 after a review of 84 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 Eastmed Enterprises, Inc. devices

FDA 510(k) Submission Details - K921128

510(k) Number K921128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1992
Decision Date June 02, 1992
Days to Decision 84 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
56d faster than avg
Panel avg: 140d · This submission: 84d
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 23
Devices cleared under the same product code (BSR) and FDA review panel - the closest regulatory comparables to K921128.
SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE
K935797 · Stebar Instrument Corp. · Jan 1994
LIGHTED INTUBATION SYLET
K932081 · Aaron Medical, Inc. · Jul 1993
STYLET AND TRACHEAL LIGHTWAND (STL)
K922842 · Laerdal California, Inc. · Dec 1992
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