Cleared Traditional

MEDILOG STRESSLINK (K951128) - FDA 510(k) Clearance

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

K951128 · Oxford Medical, Inc. · Cardiovascular device
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Aug 1996
Decision
534d
Days
Class 2
Risk

K951128 is an FDA 510(k) clearance for the MEDILOG STRESSLINK. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Oxford Medical, Inc. (Clearwater, US). The FDA issued a Cleared decision on August 28, 1996 after a review of 534 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Oxford Medical, Inc. devices

Submission Details

510(k) Number K951128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1995
Decision Date August 28, 1996
Days to Decision 534 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
409d slower than avg
Panel avg: 125d · This submission: 534d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 119
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