Cleared Traditional

K904766 - DEVILBISS MODEL 7352 SERIES

K904766 is an FDA 510(k) clearance for DEVILBISS MODEL 7352 SERIES, manufactured by Devilbiss Health Care, Inc.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K904766 · Devilbiss Health Care, Inc. · Anesthesiology device
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Mar 1991
Decision
155d
Days
Class 2
Risk

K904766 is an FDA 510(k) clearance for the DEVILBISS MODEL 7352 SERIES. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Devilbiss Health Care, Inc. (Somerset, US). The FDA issued a Cleared decision on March 26, 1991 after a review of 155 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 Devilbiss Health Care, Inc. devices

FDA 510(k) Submission Details - K904766

510(k) Number K904766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1990
Decision Date March 26, 1991
Days to Decision 155 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 140d · This submission: 155d
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 316
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K904766.
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SLEEPAP
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RESPIRONICS BIPAP REMOTE CONTROL UNIT
K905540 · Respironics, Inc. · Jan 1991
MODIFIED INFANT NASAL CANNULAE ASSEMBLY
K895031 · Ackrad Laboratories · Oct 1989
H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP
K871351 · Holter-Hausner Intl. · May 1987