Cleared Traditional

BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651 (K971892) - FDA 510(k) Clearance

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

K971892 · Biomedical Horizons, Inc. · Cardiovascular device
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Aug 1998
Decision
440d
Days
Class 2
Risk

K971892 is an FDA 510(k) clearance for the BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Biomedical Horizons, Inc. (Jackson, US). The FDA issued a Cleared decision on August 5, 1998 after a review of 440 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Biomedical Horizons, Inc. devices

Submission Details

510(k) Number K971892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1997
Decision Date August 05, 1998
Days to Decision 440 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
315d slower than avg
Panel avg: 125d · This submission: 440d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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 - JOW Sleeve, Limb, Compressible

All 349
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