Cleared Traditional

K984194 - HP M2376A DEVICE LINK SYSTEM

K984194 is an FDA 510(k) clearance for HP M2376A DEVICE LINK SYSTEM, manufactured by Hewlett-Packard Co.. The device is a Class 2 Gastroenterology & Urology device with product code MQS cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K984194 · Hewlett-Packard Co. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
158d
Days
Class 2
Risk

K984194 is an FDA 510(k) clearance for the HP M2376A DEVICE LINK SYSTEM. Classified as System, Hemodialysis, Access Recirculation Monitoring (product code MQS), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on April 30, 1999 after a review of 158 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology device 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hewlett-Packard Co. devices

FDA 510(k) Submission Details - K984194

510(k) Number K984194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1998
Decision Date April 30, 1999
Days to Decision 158 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 131d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQS Device Classification - Class 2, Special Controls

Product Code MQS System, Hemodialysis, Access Recirculation Monitoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - MQS System, Hemodialysis, Access Recirculation Monitoring

All 16
Devices cleared under the same product code (MQS) and FDA review panel - the closest regulatory comparables to K984194.
TRANSONIC FLOW-QC SET MODEL ADT1010
K021571 · Transonic Systems, Inc. · Aug 2002
HP M2376A DEVICE LINK SYSTEM
K993587 · Hewlett-Packard Co. · Jan 2000
CRIT-LINE MONITOR III (CLM III)
K992227 · In-Line Diagnostics Corp. · Jul 1999
MODIFICATION OF CRIT-LINE MONITOR III (CLM III)
K982412 · In-Line Diagnostics Corp. · Oct 1998
TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO
K980906 · Transonic Systems, Inc. · Oct 1998
CRIT-LINE MONITOR (CLMIII)
K972470 · In-Line Diagnostics Corp. · Dec 1997