Cleared Traditional

K130554 - REDSENSE ALARM SYSTEM (FDA 510(k) Clearance)

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

K130554 · Redsense Medical AB · Gastroenterology & Urology device
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Nov 2013
Decision
263d
Days
Class 2
Risk

K130554 is an FDA 510(k) clearance for the REDSENSE ALARM SYSTEM. Classified as Autonomous Extracorporeal Blood Leak Detector/alarm (product code ODX), Class II - Special Controls.

Submitted by Redsense Medical AB (Halmstad, SE). The FDA issued a Cleared decision on November 22, 2013 after a review of 263 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 Redsense Medical AB devices

Submission Details

510(k) Number K130554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2013
Decision Date November 22, 2013
Days to Decision 263 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
133d slower than avg
Panel avg: 130d · This submission: 263d
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.