Cleared Traditional

K953677 - LIGHTED FLEXGUIDE (MODIFICATION)

K953677 is an FDA 510(k) clearance for LIGHTED FLEXGUIDE (MODIFICATION), manufactured by Scientific Sales Intl., Inc.. The device is a Class 1 Anesthesiology device with product code BSR cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K953677 · Scientific Sales Intl., Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
18d
Days
Class 1
Risk

K953677 is an FDA 510(k) clearance for the LIGHTED FLEXGUIDE (MODIFICATION). Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Scientific Sales Intl., Inc. (Kalamazoo, US). The FDA issued a Cleared decision on August 25, 1995 after a review of 18 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 Scientific Sales Intl., Inc. devices

FDA 510(k) Submission Details - K953677

510(k) Number K953677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1995
Decision Date August 25, 1995
Days to Decision 18 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 140d · This submission: 18d
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 K953677.
TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
K954771 · Laerdal Medical Corp. · May 1996
MOLLOY INTUBATING STYLETTE
K943104 · Molloy Corp. · Apr 1996
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
FLEXTITIP STYLETTE
K950380 · Polamedco, Inc. · Feb 1995