Cleared Traditional

K834089 - COMFIT

K834089 is an FDA 510(k) clearance for COMFIT, manufactured by Ackrad Laboratories. The device is a Class 1 Anesthesiology device with product code JAY cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K834089 · Ackrad Laboratories · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1983
Decision
31d
Days
Class 1
Risk

K834089 is an FDA 510(k) clearance for the COMFIT. Classified as Support, Breathing Tube (product code JAY), Class I - General Controls.

Submitted by Ackrad Laboratories (Walker, US). The FDA issued a Cleared decision on December 29, 1983 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5280 - 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 - K834089

510(k) Number K834089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1983
Decision Date December 29, 1983
Days to Decision 31 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
109d faster than avg
Panel avg: 140d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

JAY Device Classification - Class 1, General Controls

Product Code JAY Support, Breathing Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5280
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 - JAY Support, Breathing Tube

Devices cleared under the same product code (JAY) and FDA review panel - the closest regulatory comparables to K834089.
COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK
K850309 · Ackrad Laboratories · Feb 1985
ENDOTRACHEAL TUBE HOLDER
K802675 · Respiratory Support Products, Inc. · Nov 1980
ADJUSTABLE TUBE TREE FOR ANESTH. HOSES
K792148 · Medical Innovations Corp. · Nov 1979
TUBE-STRAP
K791781 · Olympic Medical Corp. · Sep 1979
CLAMP BE-152
K770628 · Instrumentation Industries, Inc. · May 1977
FLEX ARM BE 122, CLAMP 122-27
K770631 · Instrumentation Industries, Inc. · May 1977