Cleared Traditional

K964543 - INFRASONICS ADULT VENTILATOR TRENDING O...

K964543 is an FDA 510(k) clearance for INFRASONICS ADULT VENTILATOR TRENDING O..., manufactured by Nellcor Puritan Bennett, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K964543 · Nellcor Puritan Bennett, Inc. · Anesthesiology device
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Feb 1997
Decision
93d
Days
Class 2
Risk

K964543 is an FDA 510(k) clearance for the INFRASONICS ADULT VENTILATOR TRENDING OPTION. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Nellcor Puritan Bennett, Inc. (Pleasanton, US). The FDA issued a Cleared decision on February 14, 1997 after a review of 93 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 Nellcor Puritan Bennett, Inc. devices

FDA 510(k) Submission Details - K964543

510(k) Number K964543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received November 13, 1996
Decision Date February 14, 1997
Days to Decision 93 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
47d faster than avg
Panel avg: 140d · This submission: 93d
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K964543.
BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT
K972203 · Allied Healthcare Products, Inc. · Nov 1997
SERVO VENTILATOR 300A
K970839 · Siemens Elema AB · Oct 1997
NELLCOR PURITAN BENNETT GEMINI
K972248 · Nellcor Puritan Bennett, Inc. · Sep 1997
SERVO VENTILATOR 300 COMPUTER INTERFACE
K960010 · Siemens Elema AB · Oct 1996
SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990
K960168 · Siemens Elema AB · Oct 1996
OHMEDA 7900 ANESTHESIA VENTILATOR
K960964 · Ohmeda Medical · Sep 1996