Cleared Traditional

MODEL 7200AE VENTILATOR FLOW BY 2.0 OR OPTION 50 (K920002) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 72
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K920002.
POWER PACK 350/BATTERY PACK 351
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SERVO GRAPHICS
K923444 · Siemens Medical Solutions USA, Inc. · Mar 1993
MERIDIAN MEDICAL SYSTEMS VOLUME VENTILATOR CIRCUIT
K925262 · Merit Medical Systems, Inc. · Jan 1993
HAYEK OSCILLATOR, MODIFICATION
K921726 · Respironics, Inc. · Apr 1992
OHMEDA 7810 ANESTHESIA VENTILATOR
K910847 · Ohmeda Medical · May 1991
OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE
K902084 · Ohmeda Medical · Oct 1990