Cleared Traditional

K981576 - MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A

K981576 is an FDA 510(k) clearance for MULTI-PARAMETER MODULE, manufactured by Hewlett-Packard GmbH. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K981576 · Hewlett-Packard GmbH · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K981576

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
Combination Product No
PCCP Authorized No
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.

MHX Device Classification - Class 2, Special Controls

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)

All 424
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K981576.
VITAL SIGNS MONITOR
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NPB3900 SERIES PATIENT MONITORS
K980411 · Analogic Corp. · Aug 1998
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WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS
K973474 · Witt Biomedical Corporation · Mar 1998
OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM
K971840 · Invivo Research, Inc. · Mar 1998
VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK 3100/3000/VITALMAX 800+/MINIPACK 300
K970445 · Pace Tech Medical Monitors, Inc. · Jan 1998
K981576 · MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A
Download PDF FDA Summary Hewlett-Packard GmbH