Cleared Traditional

K904954 - CONDOR DIGITAL INFLATION SYRINGE

K904954 is an FDA 510(k) clearance for CONDOR DIGITAL INFLATION SYRINGE, manufactured by Professional Medical Services. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K904954 · Professional Medical Services · Cardiovascular device
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Jan 1991
Decision
72d
Days
Class 2
Risk

K904954 is an FDA 510(k) clearance for the CONDOR DIGITAL INFLATION SYRINGE. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Professional Medical Services (North Salt Lake, US). The FDA issued a Cleared decision on January 16, 1991 after a review of 72 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Professional Medical Services devices

FDA 510(k) Submission Details - K904954

510(k) Number K904954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1990
Decision Date January 16, 1991
Days to Decision 72 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 125d · This submission: 72d
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 38
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K904954.
MEDFLATOR INFLATION SYSTEM
K910958 · Medex, Inc. · Jul 1991
BIPOLAR FORCEPS
K912544 · Everest Medical Corp. · Jun 1991
CONDOR ANALOG INFLATION SYRINGE
K904508 · Professional Medical Services · Apr 1991
MORSE BALLOON INFLATION DEVICE
K904275 · North American Instrument Corp. · Jan 1991
DISPOSABLE INFLATION GAUGE
K902695 · Cook Urological, Inc. · Dec 1990
INFLATION/DEFLATION DEVICE
K904394 · Boston Scientific Corp · Dec 1990