Cleared Traditional

K936000 - PURITAN-BENNETT CASCADE I SERIES HUMIDI...

K936000 is an FDA 510(k) clearance for PURITAN-BENNETT CASCADE I SERIES HUMIDI..., manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K936000 · Puritan Bennett Corp. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Aug 1994
Decision
243d
Days
Class 2
Risk

K936000 is an FDA 510(k) clearance for the PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Carlsbad, US). The FDA issued a Cleared decision on August 15, 1994 after a review of 243 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - 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 - K936000

510(k) Number K936000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1993
Decision Date August 15, 1994
Days to Decision 243 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
103d slower than avg
Panel avg: 140d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTT Device Classification - Class 2, Special Controls

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
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 - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 109
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K936000.
WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER
K962223 · Marquest Medical Products, Inc. · Jan 1997
SLEEPNET HUMIDIFIER,(84200 PACKAGED)
K963025 · Sleepnet Corporation · Nov 1996
HUMIDIFIER
K945782 · Respironics, Inc. · Mar 1996
MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM
K903138 · Marquest Medical Products, Inc. · Oct 1990
PRECISION MEDICAL DISPOSABLE HUMIDIFIER
K902970 · Precision Medical, Inc. · Aug 1990
DEVILBISS AP-50 COMPRESSOR/NEBULIZER
K900602 · Devilbiss Health Care, Inc. · Apr 1990