Cleared Traditional

K915312 - MODIFICATION PURITAN BENETT COMPANION 2...

K915312 is an FDA 510(k) clearance for MODIFICATION PURITAN BENETT COMPANION 2..., manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K915312 · Puritan Bennett Corp. · Anesthesiology device
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Jul 1992
Decision
229d
Days
Class 2
Risk

K915312 is an FDA 510(k) clearance for the MODIFICATION PURITAN BENETT COMPANION 2801 VOL VEN. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on July 8, 1992 after a review of 229 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 - K915312

510(k) Number K915312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1991
Decision Date July 08, 1992
Days to Decision 229 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 140d · This submission: 229d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K915312.
PURITAN-BENNETT MODEL 7200AE VENTILATOR
K923809 · Puritan Bennett Corp. · Oct 1992
PEDIATRIC VENTILATOR AND PARTNER VOLUME MONITOR
K915488 · Bird Products Corp. · Oct 1992
MODEL 6213 REMOTE ALARM
K914424 · Aequitron Medical, Inc. · Sep 1992
BEAR 7 VENTILATOR
K912619 · Bear Medical Systems, Inc. · Jun 1992
HAYEK OSCILLATOR, MODIFICATION
K921726 · Respironics, Inc. · Apr 1992
BIRD NEBULIZATION SYNCHRONIZER
K911336 · Bird Products Corp. · Nov 1991