Cleared Traditional

INFRASONICS ADULT VENTILATOR TRENDING OPTION (K964543) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 74
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K964543.
SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K022132 · Siemens Medical Solutions USA, Inc. · Sep 2002
ESPIRT
K001208 · Respironics, Inc. · May 2000
ESPRIT VENTILATOR
K981072 · Respironics, Inc. · Nov 1998
OHMEDA 7900 ANESTHESIA VENTILATOR
K960964 · Ohmeda Medical · Sep 1996
POWER PACK 350/BATTERY PACK 351
K923992 · Siemens Medical Solutions USA, Inc. · Apr 1993
SERVO GRAPHICS
K923444 · Siemens Medical Solutions USA, Inc. · Mar 1993