Cleared Traditional

K953875 - CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)

K953875 is an FDA 510(k) clearance for CRIT-LINE HEMATOCRIT ALERT (MODIFICATION), manufactured by In-Line Diagnostics Corp.. The device is a Class 2 Gastroenterology & Urology device with product code MQS cleared through the Traditional 510(k) pathway after a 391-day FDA review.

K953875 · In-Line Diagnostics Corp. · Gastroenterology & Urology device
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Jul 1996
Decision
391d
Days
Class 2
Risk

K953875 is an FDA 510(k) clearance for the CRIT-LINE HEMATOCRIT ALERT (MODIFICATION). Classified as System, Hemodialysis, Access Recirculation Monitoring (product code MQS), Class II - Special Controls.

Submitted by In-Line Diagnostics Corp. (Riverdale, US). The FDA issued a Cleared decision on July 23, 1996 after a review of 391 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 In-Line Diagnostics Corp. devices

FDA 510(k) Submission Details - K953875

510(k) Number K953875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1995
Decision Date July 23, 1996
Days to Decision 391 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
260d slower than avg
Panel avg: 131d · This submission: 391d
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 K953875.
CRIT-LINE MONITOR (CLMIII)
K972470 · In-Line Diagnostics Corp. · Dec 1997
HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)
K960817 · Transonic Systems, Inc. · Feb 1997
COBE HEMODYNAMIC RECIRCULATION MONITOR
K954003 · Cobe Renal Care, Inc. · Feb 1997
FRESENIUS BLOOD TEMPERATURE MONITOR
K941460 · Fresenius USA, Inc. · Jul 1996
KNOW-RECIRC
K953551 · H&H Control Systems · Jun 1996