Cleared Traditional

K833632 - ARIES MEDICAL MODEL 700

K833632 is the FDA 510(k) clearance for ARIES MEDICAL MODEL 700 by Aries Medical, Inc.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K833632 · Aries Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1984
Decision
212d
Days
Class 2
Risk

K833632 is an FDA 510(k) clearance for the ARIES MEDICAL MODEL 700. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Aries Medical, Inc. (Walker, US). The FDA issued a Cleared decision on May 16, 1984 after a review of 212 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3535 - 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 Aries Medical, Inc. devices

Submission Details

510(k) Number K833632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1983
Decision Date May 16, 1984
Days to Decision 212 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 125d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSP System, Balloon, Intra-aortic And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3535
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 - DSP System, Balloon, Intra-aortic And Control

All 107
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K833632.
DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO
K850482 · Datascope Corp. · Aug 1985
IABP #90 SYSTEM
K831235 · Datascope Corp. · Feb 1985
PERCOR 9.5 FR IAB ON DATASCOPE CO2
K833828 · Datascope Corp. · Feb 1985
PECOR 8.5 FRENCH IAB ON A DATASCOPE
K831307 · Datascope Corp. · Nov 1983
FRENCH INTRA-AORTIC 9.5 BALLOON ON KON
K831397 · Datascope Corp. · Nov 1983
EK COMBI MSG-1
K830410 · Jedmed Instrument Co. · Apr 1983