Cleared Traditional

PURITAN-BENNETT COMPANION 320 I/E (K934804) - FDA 510(k) Clearance

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

K934804 · Puritan Bennett Corp. · Anesthesiology device
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Feb 1995
Decision
508d
Days
Class 2
Risk

K934804 is an FDA 510(k) clearance for the PURITAN-BENNETT COMPANION 320 I/E. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Lenexa, US). The FDA issued a Cleared decision on February 27, 1995 after a review of 508 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Puritan Bennett Corp. devices

Submission Details

510(k) Number K934804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1993
Decision Date February 27, 1995
Days to Decision 508 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
368d slower than avg
Panel avg: 140d · This submission: 508d
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 119
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K934804.
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K954207 · Respironics, Inc. · Jan 1996
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K953341 · Respironics, Inc. · Jan 1996
SPECTRUM(TM) MASK
K936047 · Respironics, Inc. · Mar 1995
NASAL/ORAL MASK
K925587 · Respironics, Inc. · Sep 1993
TOTAL FACE MASK
K925920 · Respironics, Inc. · Jul 1993
REMSTAR WTIH RAMP AND REMOTE MODIFICATION
K920699 · Respironics, Inc. · Dec 1992