Cleared Traditional

K925591 - MERIDIAN MEDICAL SYSTEMS HYPER INFLATIO...

K925591 is an FDA 510(k) clearance for MERIDIAN MEDICAL SYSTEMS HYPER INFLATIO..., manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code BZR cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K925591 · Merit Medical Systems, Inc. · Anesthesiology device
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Sep 1993
Decision
315d
Days
Class 2
Risk

K925591 is an FDA 510(k) clearance for the MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on September 16, 1993 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5330 - 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 Merit Medical Systems, Inc. devices

FDA 510(k) Submission Details - K925591

510(k) Number K925591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1992
Decision Date September 16, 1993
Days to Decision 315 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
175d slower than avg
Panel avg: 140d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZR Device Classification - Class 2, Special Controls

Product Code BZR Mixer, Breathing Gases, Anesthesia Inhalation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5330
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 - BZR Mixer, Breathing Gases, Anesthesia Inhalation

All 22
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K925591.
PRECISION BLENDER
K053232 · Precision Medical, Inc. · Jan 2006
SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES
K992503 · Sechrist Industries, Inc. · Aug 1999
BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER
K973646 · Bird Products Corp. · May 1998
BIRD SENTRY AIR/OXYGEN MICROBLENDER
K911962 · Bird Products Corp. · Oct 1991
LOW FLOW N2O/02O MICROBLENDER
K900722 · Bird Products Corp. · Jul 1990
BIRD MICROBLENDER M.R.I.
K895695 · Bird Products Corp. · Jul 1990