Cleared Traditional

K860798 - ARF-1500 CONTINUOUS VENTILATOR

K860798 is the FDA 510(k) clearance for ARF-1500 CONTINUOUS VENTILATOR by Medimex, Inc.. It is a Class 2 Anesthesiology device (product code CBK) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K860798 · Medimex, Inc. · Anesthesiology device
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Jul 1986
Decision
128d
Days
Class 2
Risk

K860798 is an FDA 510(k) clearance for the ARF-1500 CONTINUOUS VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Medimex, Inc. (West Hempstead, US). The FDA issued a Cleared decision on July 10, 1986 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medimex, Inc. devices

Submission Details

510(k) Number K860798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1986
Decision Date July 10, 1986
Days to Decision 128 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 140d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 122
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K860798.
CPU GRAPH
K863546 · Ohmeda Medical · Sep 1986
COMPANION 2500 PORTABLE VOLUME VENTILATOR
K862810 · Puritan Bennett Corp. · Sep 1986
7200 MICROPROCESS VENT SYS/MODEL 7202 DISPLAY OPT
K862604 · Puritan Bennett Corp. · Aug 1986
ENGSTROM ERICA II RESPIRATOR
K862025 · Gambro, Inc. · Jun 1986
COMPANION 2800 VOLUME VENTILATOR REMOTE ALARM
K861488 · Puritan Bennett Corp. · May 1986
COMPANION 2800 VOLUME VENTILATOR REMOT ALARM
K860675 · Puritan Bennett Corp. · Apr 1986