Cleared Traditional

K950687 - EXTERNAL HELIUM SUPPLY (ACCESSORY FOR I...

K950687 is the FDA 510(k) clearance for EXTERNAL HELIUM SUPPLY (ACCESSORY FOR I... by Belmont Instrument Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K950687 · Belmont Instrument Corp. · Cardiovascular device
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May 1995
Decision
99d
Days
Class 2
Risk

K950687 is an FDA 510(k) clearance for the EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP). Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Belmont Instrument Corp. (Billerica, US). The FDA issued a Cleared decision on May 24, 1995 after a review of 99 days - within the typical 510(k) review window.

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 Belmont Instrument Corp. devices

Submission Details

510(k) Number K950687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1995
Decision Date May 24, 1995
Days to Decision 99 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 125d · This submission: 99d
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 K950687.
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K940298 · Boston Scientific Corp · Apr 1995
9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER
K943919 · Boston Scientific Corp · Mar 1995