Cleared Traditional

K925262 - MERIDIAN MEDICAL SYSTEMS VOLUME VENTILA...

K925262 is an FDA 510(k) clearance for MERIDIAN MEDICAL SYSTEMS VOLUME VENTILA..., manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K925262 · Merit Medical Systems, Inc. · Anesthesiology device
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Jan 1993
Decision
95d
Days
Class 2
Risk

K925262 is an FDA 510(k) clearance for the MERIDIAN MEDICAL SYSTEMS VOLUME VENTILATOR CIRCUIT. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 22, 1993 after a review of 95 days - within the typical 510(k) review window.

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 Merit Medical Systems, Inc. devices

FDA 510(k) Submission Details - K925262

510(k) Number K925262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1992
Decision Date January 22, 1993
Days to Decision 95 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
45d faster than avg
Panel avg: 140d · This submission: 95d
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 K925262.
BIRD 8400ST ADULT VOLUME VENTILATOR
K921387 · Bird Products Corp. · Mar 1993
SERVO GRAPHICS
K923444 · Siemens Medical Solutions USA, Inc. · Mar 1993
BIRD GRAPHICS MONITOR
K920113 · Bird Products Corp. · Feb 1993
VENTILATOR INTERFACE 9291/4
K922314 · S & W Medico Teknik · Dec 1992
MODEL 7200AE VENTILATOR FLOW BY 2.0 OR OPTION 50
K920002 · Puritan Bennett Corp. · Nov 1992
PURITAN-BENNETT MODEL 7200AE VENTILATOR
K923809 · Puritan Bennett Corp. · Oct 1992