Cleared Traditional

K103242 - REDSENSE-ALARM UNIT AND SENSOR (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K103242 · Redsense Medical AB · Gastroenterology & Urology device
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Feb 2011
Decision
100d
Days
Class 2
Risk

K103242 is an FDA 510(k) clearance for the REDSENSE-ALARM UNIT AND SENSOR. Classified as Autonomous Extracorporeal Blood Leak Detector/alarm (product code ODX), Class II - Special Controls.

Submitted by Redsense Medical AB (Fridley, US). The FDA issued a Cleared decision on February 10, 2011 after a review of 100 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K103242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2010
Decision Date February 10, 2011
Days to Decision 100 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 130d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODX Autonomous Extracorporeal Blood Leak Detector/alarm
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
Definition To Detect The Presence Of Blood Leaking From An Extracorporeal Connection Or Needle Site In Hemodialysis Patients And Alert The User Or Attending Staff. The Device Detects Colormetric, Chemical, Or Light Modulation Caused By Exposure To Leaking Blood.
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.