Cleared Traditional

K940425 - IMAGYN MEDICAL INFLATION DEVICE WITH NO...

K940425 is an FDA 510(k) clearance for IMAGYN MEDICAL INFLATION DEVICE WITH NO..., manufactured by Imagyn Medical, Inc.. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K940425 · Imagyn Medical, Inc. · Cardiovascular device
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Aug 1994
Decision
182d
Days
Class 2
Risk

K940425 is an FDA 510(k) clearance for the IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Imagyn Medical, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on August 1, 1994 after a review of 182 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Imagyn Medical, Inc. devices

FDA 510(k) Submission Details - K940425

510(k) Number K940425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1994
Decision Date August 01, 1994
Days to Decision 182 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 125d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAV Device Classification - Class 2, Special Controls

Product Code MAV Syringe, Balloon Inflation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - MAV Syringe, Balloon Inflation

All 33
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K940425.
OSCILFLATOR
K952566 · Surgical Technologies, Inc. · Aug 1995
MONARCH AP(TM)
K943597 · Merit Medical Systems, Inc. · Feb 1995
MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE
K940896 · Medex, Inc. · Aug 1994
10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE
K922573 · Boston Scientific Corp · Dec 1992
ACS ANGIOTRAK(TM) SYSTEM
K921719 · Advanced Cardiovascular Systems, Inc. · Aug 1992
MONARCH(TM) INFLATION SYRINGE
K913994 · Merit Medical Systems, Inc. · Feb 1992