Cleared Traditional

K920002 - MODEL 7200AE VENTILATOR FLOW BY 2.0 OR ...

K920002 is an FDA 510(k) clearance for MODEL 7200AE VENTILATOR FLOW BY 2.0 OR ..., 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 313-day FDA review.

K920002 · Puritan Bennett Corp. · Anesthesiology device
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Nov 1992
Decision
313d
Days
Class 2
Risk

K920002 is an FDA 510(k) clearance for the MODEL 7200AE VENTILATOR FLOW BY 2.0 OR OPTION 50. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Carlsbad, US). The FDA issued a Cleared decision on November 10, 1992 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K920002

510(k) Number K920002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1992
Decision Date November 10, 1992
Days to Decision 313 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
173d slower than avg
Panel avg: 140d · This submission: 313d
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 K920002.
BIRD GRAPHICS MONITOR
K920113 · Bird Products Corp. · Feb 1993
MERIDIAN MEDICAL SYSTEMS VOLUME VENTILATOR CIRCUIT
K925262 · Merit Medical Systems, Inc. · Jan 1993
VENTILATOR INTERFACE 9291/4
K922314 · S & W Medico Teknik · Dec 1992
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