Cleared Traditional

K162877 - VOCSN Unified Respiratory System

K162877 is an FDA 510(k) clearance for VOCSN Unified Respiratory System, manufactured by Ventec Life Systems, Inc.. The device is a Class 2 General Hospital device with product code CBK cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K162877 · Ventec Life Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
175d
Days
Class 2
Risk

K162877 is an FDA 510(k) clearance for the VOCSN Unified Respiratory System. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Ventec Life Systems, Inc. (Bothell, US). The FDA issued a Cleared decision on April 7, 2017 after a review of 175 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5895 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Ventec Life Systems, Inc. devices

FDA 510(k) Submission Details - K162877

510(k) Number K162877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2016
Decision Date April 07, 2017
Days to Decision 175 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 129d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

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 General Hospital devices follow this clearance model.

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 327
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K162877.
Puritan Bennett 980 Ventilator System
K162738 · Covidien · Oct 2017
731 Series Ventilators
K162832 · ZOLL Medical Corporation · Aug 2017
HAMILTON-C3
K161450 · Hamilton Medical AG · Apr 2017
HAMILTON-MR1
K153046 · Hamilton Medical AG · Sep 2016
Astral 100/150
K152068 · Resmed, Ltd. · May 2016
SERVO-U Ventilator System, SERVO-n Ventilator System
K151814 · Maquet Critical Care AB · Dec 2015