Cleared Traditional

K865108 - N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODU...

K865108 is an FDA 510(k) clearance for N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODU..., manufactured by Ackrad Laboratories. The device is a Class 1 Anesthesiology device with product code BSR cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K865108 · Ackrad Laboratories · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1987
Decision
41d
Days
Class 1
Risk

K865108 is an FDA 510(k) clearance for the N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE. Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Ackrad Laboratories (Cranford, US). The FDA issued a Cleared decision on February 10, 1987 after a review of 41 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 Ackrad Laboratories devices

FDA 510(k) Submission Details - K865108

510(k) Number K865108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1986
Decision Date February 10, 1987
Days to Decision 41 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
99d faster than avg
Panel avg: 140d · This submission: 41d
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 K865108.
AUGUSTINE STYLET
K910659 · Augustine Medical, Inc. · May 1991
STYLET TRACHAEL TUBE
K905133 · Medical Devices, Inc. · Apr 1991
BIVONA ENDOTRACHEAL TUBE STYLET
K905052 · Bivona Medical Technologies · Apr 1991
ACKRAD ENDOTRACHEAL TUBE INTRODUCING GUIDE
K844557 · Ackrad Laboratories · Dec 1984
TUBE-STAT
K843490 · Concept, Inc. · Oct 1984
SHERI-I-SLIP INTUBATING STYLET
K832773 · Sheridan Catheter Corp. · Sep 1983