Cleared Traditional

K960518 - THE PURITAN-BENNETT 318 PLUS NASAL CPAP...

K960518 is an FDA 510(k) clearance for THE PURITAN-BENNETT 318 PLUS NASAL CPAP..., manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K960518 · Puritan Bennett Corp. · Anesthesiology device
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May 1996
Decision
94d
Days
Class 2
Risk

K960518 is an FDA 510(k) clearance for the THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM. 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 May 9, 1996 after a review of 94 days - within the typical 510(k) review window.

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 Corp. devices

FDA 510(k) Submission Details - K960518

510(k) Number K960518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1996
Decision Date May 09, 1996
Days to Decision 94 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
46d faster than avg
Panel avg: 140d · This submission: 94d
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 285
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K960518.
SOLO CPAP SYSTEM
K961626 · Respironics, Inc. · Jul 1996
MAESTRO CLINICAL REMOTE CONTROL
K954572 · Respironics, Inc. · Jun 1996
THE IMS DPAP MASK, IMS MODEL NUMBER 82000
K953697 · Sleepnet Corporation · Jun 1996
MODEL #7354
K950849 · Devilbiss Health Care, Inc. · Feb 1996
RESPIRONICS MONARCH MINI MASK
K945938 · Respironics, Inc. · Jan 1996
MODEL 7355
K952491 · Devilbiss Health Care, Inc. · Jan 1996