Cleared Traditional

ANGIOSCAN FLO MAD SPECTRUM ANALYZER (K834525) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K834525 · Unigon Industries, Inc. · Cardiovascular device
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May 1984
Decision
154d
Days
Class 2
Risk

K834525 is an FDA 510(k) clearance for the ANGIOSCAN FLO MAD SPECTRUM ANALYZER. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Unigon Industries, Inc. (Walker, US). The FDA issued a Cleared decision on May 23, 1984 after a review of 154 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2880 - 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 Unigon Industries, Inc. devices

Submission Details

510(k) Number K834525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1983
Decision Date May 23, 1984
Days to Decision 154 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 125d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOP Transducer, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2880
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 - JOP Transducer, Ultrasonic

All 12
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K834525.
CARDIAC SECTOR PROBE 3.5. MHZ
K850145 · Siemens Medical Solutions USA, Inc. · Apr 1985
CARDIAC SECTOR PROBE 5.0 MHZ
K850216 · Siemens Medical Solutions USA, Inc. · Apr 1985
TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO
K843262 · Hewlett-Packard Co. · Aug 1984
USCI DOPPLER CATHETER SYSTEM
K810414 · C.R. Bard, Inc. · Aug 1981