Cleared Traditional

K904508 - CONDOR ANALOG INFLATION SYRINGE

K904508 is an FDA 510(k) clearance for CONDOR ANALOG 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 180-day FDA review.

K904508 · Professional Medical Services · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
180d
Days
Class 2
Risk

K904508 is an FDA 510(k) clearance for the CONDOR ANALOG 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 April 2, 1991 after a review of 180 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 Professional Medical Services devices

FDA 510(k) Submission Details - K904508

510(k) Number K904508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1990
Decision Date April 02, 1991
Days to Decision 180 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
55d slower than avg
Panel avg: 125d · This submission: 180d
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 K904508.
CORDIS INFLATOR DEVICE
K912644 · Cordis Corp. · Sep 1991
MEDFLATOR INFLATION SYSTEM
K910958 · Medex, Inc. · Jul 1991
BIPOLAR FORCEPS
K912544 · Everest Medical Corp. · Jun 1991
CONDOR DIGITAL INFLATION SYRINGE
K904954 · Professional Medical Services · Jan 1991
MORSE BALLOON INFLATION DEVICE
K904275 · North American Instrument Corp. · Jan 1991
DISPOSABLE INFLATION GAUGE
K902695 · Cook Urological, Inc. · Dec 1990