Cleared Traditional

K910194 - COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM

K910194 is an FDA 510(k) clearance for COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM, 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 117-day FDA review.

K910194 · Puritan Bennett Corp. · Anesthesiology device
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May 1991
Decision
117d
Days
Class 2
Risk

K910194 is an FDA 510(k) clearance for the COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on May 13, 1991 after a review of 117 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 - K910194

510(k) Number K910194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1991
Decision Date May 13, 1991
Days to Decision 117 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
23d faster than avg
Panel avg: 140d · This submission: 117d
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 K910194.
SALTER LABS INFANT NASAL CPAP CANNULA
K912434 · Salter Labs · Jul 1991
INFANT NASAL CANNULAE ASSEMBLY, MODIFIED
K911780 · Ackrad Laboratories · Jun 1991
MEDTRONIC SULLIVAN NASAL CPAP SYSTEM
K905404 · Medtronic Vascular · May 1991
SLEEPER MASK SYSTEM
K904344 · Devilbiss Health Care, Inc. · May 1991
DEVILBISS MODEL 7352 SERIES
K904766 · Devilbiss Health Care, Inc. · Mar 1991
RESPIRONICS BIPAP REMOTE CONTROL UNIT
K905540 · Respironics, Inc. · Jan 1991