Cleared Traditional

K935784 - PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM

K935784 is an FDA 510(k) clearance for PURITAN-BENNETT COMPANION 320 I/E BI-LE..., manufactured by Puritan-Bennett. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K935784 · Puritan-Bennett · Anesthesiology device
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Jul 1994
Decision
219d
Days
Class 2
Risk

K935784 is an FDA 510(k) clearance for the PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Puritan-Bennett (Lenexa, US). The FDA issued a Cleared decision on July 13, 1994 after a review of 219 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 devices

FDA 510(k) Submission Details - K935784

510(k) Number K935784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1993
Decision Date July 13, 1994
Days to Decision 219 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 140d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 377
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K935784.
PURITAN-BENNETT COMPANION 320 I/E
K934804 · Puritan Bennett Corp. · Feb 1995
POSITIVE AIRWAY PRESSURE SYSTEM
K933184 · Innovative Medical Systems, Inc. · Nov 1994
CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM
K935979 · Devilbiss Health Care, Inc. · Nov 1994
REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S
K931484 · Portable Power Systems, Inc. · Feb 1994
NASAL/ORAL MASK
K925587 · Respironics, Inc. · Sep 1993
TOTAL FACE MASK
K925920 · Respironics, Inc. · Jul 1993