Cleared Traditional

K940896 - MEDFLATOR II(TM) DISPOSABLE INFLATION D...

K940896 is the FDA 510(k) clearance for MEDFLATOR II(TM) DISPOSABLE INFLATION D... by Medex, Inc.. It is a Class 2 Cardiovascular device (product code MAV) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K940896 · Medex, Inc. · Cardiovascular device
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Aug 1994
Decision
168d
Days
Class 2
Risk

K940896 is an FDA 510(k) clearance for the MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Medex, Inc. (Hilliard, US). The FDA issued a Cleared decision on August 11, 1994 after a review of 168 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 Medex, Inc. devices

Submission Details

510(k) Number K940896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1994
Decision Date August 11, 1994
Days to Decision 168 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 125d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 28
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K940896.
INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)
K961471 · Advanced Cardiovascular Systems, Inc. · May 1996
SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE
K955869 · Scimed Life Systems, Inc. · Mar 1996
MONARCH AP(TM)
K943597 · Merit Medical Systems, Inc. · Feb 1995
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