Cleared Traditional

MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES (K925364) - FDA 510(k) Clearance

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

K925364 · Merit Medical Systems, Inc. · Anesthesiology device
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Jan 1993
Decision
98d
Days
Class 2
Risk

K925364 is an FDA 510(k) clearance for the MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 28, 1993 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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

Submission Details

510(k) Number K925364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1992
Decision Date January 28, 1993
Days to Decision 98 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
42d faster than avg
Panel avg: 140d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 - BZQ Monitor, Breathing Frequency

All 34
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K925364.
COROMETRICS MODEL 510 AND 511 MONITOR
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MODEL 510 INFANT MONITOR
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MODEL 511 INFANT MONITOR
K942170 · Ge Medical Systems Information Technologies · Jun 1995
MEDICAL SAFETY CABLE AND LEAD SYSTEM
K912415 · Medtronic Vascular · Aug 1991
AR-800PA RESPIRATION MODULE
K891486 · Nihon Kohden America, Inc. · Oct 1989
MODEL 500E INFANT MONITORING SYSTEM
K873791 · Ge Medical Systems Information Technologies · Nov 1987