Cleared Traditional

PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM (K935784) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 208
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K935784.
PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM
K952292 · Puritan Bennett Corp. · Nov 1995
SPECTRUM(TM) MASK
K936047 · Respironics, Inc. · Mar 1995
PURITAN-BENNETT COMPANION 320 I/E
K934804 · Puritan Bennett Corp. · Feb 1995
NASAL/ORAL MASK
K925587 · Respironics, Inc. · Sep 1993
TOTAL FACE MASK
K925920 · Respironics, Inc. · Jul 1993
318A RESPIRATORY SUPPORT SYSTEM
K923590 · Puritan Bennett Corp. · Apr 1993