Cleared Traditional

DMR/CO2 COMBO KTI (K960468) - FDA 510(k) Clearance

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

K960468 · Nellcor Puritan Bennett, Inc. · Anesthesiology device
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Apr 1996
Decision
85d
Days
Class 2
Risk

K960468 is an FDA 510(k) clearance for the DMR/CO2 COMBO KTI. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Nellcor Puritan Bennett, Inc. (Pleasanton, US). The FDA issued a Cleared decision on April 26, 1996 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nellcor Puritan Bennett, Inc. devices

Submission Details

510(k) Number K960468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 01, 1996
Decision Date April 26, 1996
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 140d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
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 - BTM Ventilator, Emergency, Manual (resuscitator)

All 14
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K960468.
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RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE
K934699 · Respironics, Inc. · Jan 1995
BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS
K940581 · Respironics, Inc. · May 1994
BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR
K934310 · Respironics, Inc. · Dec 1993