Cleared Traditional

K981576 - MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A (FDA 510(k) Clearance)

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

K981576 · Hewlett-Packard GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
74d
Days
Class 2
Risk

K981576 is an FDA 510(k) clearance for the MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Hewlett-Packard GmbH (Boeblingen, Baden-Wttbg, DE). The FDA issued a Cleared decision on July 17, 1998 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hewlett-Packard GmbH devices

Submission Details

510(k) Number K981576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1998
Decision Date July 17, 1998
Days to Decision 74 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 125d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

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