Cleared Traditional

K963633 - VENTNET

Also marketed or referenced as:
CENTRAL MONITORING STATION

K963633 is an FDA 510(k) clearance for VENTNET, manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code MOD cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K963633 · Puritan Bennett Corp. · Anesthesiology device
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Dec 1996
Decision
96d
Days
Class 2
Risk

K963633 is an FDA 510(k) clearance for the VENTNET. Classified as Accessory To Continuous Ventilator (respirator) (product code MOD), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Tustin, US). The FDA issued a Cleared decision on December 16, 1996 after a review of 96 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 Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K963633

510(k) Number K963633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1996
Decision Date December 16, 1996
Days to Decision 96 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 140d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOD Device Classification - Class 2, Special Controls

Product Code MOD Accessory To Continuous Ventilator (respirator)
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.