Cleared Traditional

K844557 - ACKRAD ENDOTRACHEAL TUBE INTRODUCING GUIDE

K844557 is an FDA 510(k) clearance for ACKRAD ENDOTRACHEAL TUBE INTRODUCING GUIDE, 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 26-day FDA review.

K844557 · Ackrad Laboratories · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1984
Decision
26d
Days
Class 1
Risk

K844557 is an FDA 510(k) clearance for the ACKRAD 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 December 17, 1984 after a review of 26 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 - K844557

510(k) Number K844557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1984
Decision Date December 17, 1984
Days to Decision 26 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
114d faster than avg
Panel avg: 140d · This submission: 26d
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 K844557.
STYLET TRACHAEL TUBE
K905133 · Medical Devices, Inc. · Apr 1991
BIVONA ENDOTRACHEAL TUBE STYLET
K905052 · Bivona Medical Technologies · Apr 1991
N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE
K865108 · Ackrad Laboratories · Feb 1987
TUBE-STAT
K843490 · Concept, Inc. · Oct 1984
SHERI-I-SLIP INTUBATING STYLET
K832773 · Sheridan Catheter Corp. · Sep 1983
INTUBATION PROCEDURE KIT
K772046 · American Hospital Supply Corp. · Nov 1977