Cleared Traditional

K980619 - SABRATEK PATIENT HOME MANAGEMENT SYSTEM

K980619 is an FDA 510(k) clearance for SABRATEK PATIENT HOME MANAGEMENT SYSTEM, manufactured by Sabratek Corp.. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K980619 · Sabratek Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 1998
Decision
183d
Days
Class 2
Risk

K980619 is an FDA 510(k) clearance for the SABRATEK PATIENT HOME MANAGEMENT SYSTEM. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Sabratek Corp. (Niles, US). The FDA issued a Cleared decision on August 20, 1998 after a review of 183 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Sabratek Corp. devices

FDA 510(k) Submission Details - K980619

510(k) Number K980619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1998
Decision Date August 20, 1998
Days to Decision 183 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
58d slower than avg
Panel avg: 125d · This submission: 183d
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 356
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K980619.
SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTION
K990563 · Siemens Medical Solutions USA, Inc. · Mar 1999
VITAL SIGNS MONITOR
K982279 · Bci Intl., Inc. · Sep 1998
NPB3900 SERIES PATIENT MONITORS
K980411 · Analogic Corp. · Aug 1998
MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A
K981576 · Hewlett-Packard GmbH · Jul 1998
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