Cleared Traditional

PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM (K972255) - FDA 510(k) Clearance

K972255 · Pulse Biomedical, Inc. · Cardiovascular device
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Jul 1998
Decision
385d
Days
-
Risk

K972255 is an FDA 510(k) clearance for the PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM.

Submitted by Pulse Biomedical, Inc. (Norristown, US). The FDA issued a Cleared decision on July 7, 1998 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel. 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 Pulse Biomedical, Inc. devices

Submission Details

510(k) Number K972255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1997
Decision Date July 07, 1998
Days to Decision 385 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
260d slower than avg
Panel avg: 125d · This submission: 385d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -