Cleared Traditional

K935958 - CRIT-LINE BLOOD CHAMBER WITH E-BEAM

K935958 is the FDA 510(k) clearance for CRIT-LINE BLOOD CHAMBER WITH E-BEAM by In-Line Diagnostics Corp.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 419-day FDA review.

K935958 · In-Line Diagnostics Corp. · Gastroenterology & Urology device
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Jan 1995
Decision
419d
Days
Class 2
Risk

K935958 is an FDA 510(k) clearance for the CRIT-LINE BLOOD CHAMBER WITH E-BEAM. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by In-Line Diagnostics Corp. (Riverdale, US). The FDA issued a Cleared decision on January 19, 1995 after a review of 419 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all In-Line Diagnostics Corp. devices

Submission Details

510(k) Number K935958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1993
Decision Date January 19, 1995
Days to Decision 419 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
289d slower than avg
Panel avg: 130d · This submission: 419d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOC Accessories, Blood Circuit, Hemodialysis
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 115
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K935958.
ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS
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KARL STORZ MODIFIED VERESS NEEDLE AND CANNULA
K950282 · KARL STORZ Endoscopy-America, Inc. · Apr 1995
SILICONE CATHETER REPAIR KITS
K926374 · Akcess Medical Products, Inc. · Oct 1994
BARD UROTRACK II MONITORING
K924436 · C.R. Bard, Inc. · Mar 1994
BARD(R) UROTACK(R) 210 MONITORING SYSTEM
K912374 · C.R. Bard, Inc. · Mar 1992