Cleared Traditional

K915580 - BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP

K915580 is an FDA 510(k) clearance for BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP, manufactured by Belmont Instrument Corp.. The device is a Class 2 Cardiovascular device with product code DSP cleared through the Traditional 510(k) pathway after a 339-day FDA review.

K915580 · Belmont Instrument Corp. · Cardiovascular device
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Oct 1992
Decision
339d
Days
Class 2
Risk

K915580 is an FDA 510(k) clearance for the BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP. 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 October 30, 1992 after a review of 339 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K915580

510(k) Number K915580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1991
Decision Date October 30, 1992
Days to Decision 339 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
214d slower than avg
Panel avg: 125d · This submission: 339d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSP Device Classification - Class 2, Special Controls

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 141
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K915580.
SYSTEM 97
K922235 · Datascope Corp. · Apr 1993
BARD(R) INTRA AORTIC BALLOON
K924382 · C.R. Bard, Inc. · Apr 1993
SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE
K921638 · Datascope Corp. · Feb 1993
DATASCOPE SYSTEM 95
K912629 · Datascope Corp. · Mar 1992
SYSTEM 90 AND SYSTEM 90T
K913847 · Datascope Corp. · Mar 1992
DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON
K910997 · Datascope Corp. · Nov 1991