Cleared Traditional

K950380 - FLEXTITIP STYLETTE

K950380 is an FDA 510(k) clearance for FLEXTITIP STYLETTE, manufactured by Polamedco, Inc.. The device is a Class 1 Anesthesiology device with product code BSR cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K950380 · Polamedco, Inc. · Anesthesiology device
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Feb 1995
Decision
10d
Days
Class 1
Risk

K950380 is an FDA 510(k) clearance for the FLEXTITIP STYLETTE. Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Polamedco, Inc. (Inglewood, US). The FDA issued a Cleared decision on February 10, 1995 after a review of 10 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 Polamedco, Inc. devices

FDA 510(k) Submission Details - K950380

510(k) Number K950380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1995
Decision Date February 10, 1995
Days to Decision 10 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 140d · This submission: 10d
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 14
Devices cleared under the same product code (BSR) and FDA review panel - the closest regulatory comparables to K950380.
RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE
K955238 · Rusch Intl. · Feb 1996
RUSCH ENDOTRACHEAL TUBE STYLET
K952100 · Rusch, Inc. · Aug 1995
AIRGUIDE STYLETTE
K950713 · Polamedco, Inc. · May 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