Cleared Traditional

K980906 - TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO

K980906 is an FDA 510(k) clearance for TRANSONIC HEMODIALYSIS MONITOR, manufactured by Transonic Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MQS cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K980906 · Transonic Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
210d
Days
Class 2
Risk

K980906 is an FDA 510(k) clearance for the TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO. Classified as System, Hemodialysis, Access Recirculation Monitoring (product code MQS), Class II - Special Controls.

Submitted by Transonic Systems, Inc. (Ithaca, US). The FDA issued a Cleared decision on October 6, 1998 after a review of 210 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 Transonic Systems, Inc. devices

FDA 510(k) Submission Details - K980906

510(k) Number K980906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1998
Decision Date October 06, 1998
Days to Decision 210 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
79d slower than avg
Panel avg: 131d · This submission: 210d
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 8
Devices cleared under the same product code (MQS) and FDA review panel - the closest regulatory comparables to K980906.
TRANSONIC FLOW-QC SET MODEL ADT1010
K021571 · Transonic Systems, Inc. · Aug 2002
HP M2376A DEVICE LINK SYSTEM
K993587 · Hewlett-Packard Co. · Jan 2000
HP M2376A DEVICE LINK SYSTEM
K984194 · Hewlett-Packard Co. · Apr 1999
HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)
K960817 · Transonic Systems, Inc. · Feb 1997
FRESENIUS BLOOD TEMPERATURE MONITOR
K941460 · Fresenius USA, Inc. · Jul 1996