Cleared Traditional

K953676 - BREEZE DIGITAL INFLATION DEVICE

K953676 is an FDA 510(k) clearance for BREEZE DIGITAL INFLATION DEVICE, manufactured by Namic. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K953676 · Namic · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
235d
Days
Class 2
Risk

K953676 is an FDA 510(k) clearance for the BREEZE DIGITAL INFLATION DEVICE. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Namic (Glens Falls, US). The FDA issued a Cleared decision on March 29, 1996 after a review of 235 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 Namic devices

FDA 510(k) Submission Details - K953676

510(k) Number K953676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1995
Decision Date March 29, 1996
Days to Decision 235 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 125d · This submission: 235d
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 47
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K953676.
MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT
K960983 · Medtronics Interventional Vascular · May 1996
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
USCI IDEAL PTCA KIT
K953522 · Ryder Intl. Corp. · Apr 1996
SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE
K955869 · Scimed Life Systems, Inc. · Mar 1996
OSCILFLATOR
K952566 · Surgical Technologies, Inc. · Aug 1995
MONARCH AP(TM)
K943597 · Merit Medical Systems, Inc. · Feb 1995