Cleared Traditional

K242269 - SC+ Hemodialysis Device (SC-14269) (FDA 510(k) Clearance)

Also includes:
Dialysate Cartridge (SC-14656) Blood Tube Set (SC-14651)

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

K242269 · Quanta Dialysis Technologies, Ltd. · Gastroenterology & Urology device
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Nov 2024
Decision
92d
Days
Class 2
Risk

K242269 is an FDA 510(k) clearance for the SC+ Hemodialysis Device (SC-14269). Classified as Hemodialysis System For Home Use (product code ONW), Class II - Special Controls.

Submitted by Quanta Dialysis Technologies, Ltd. (Warwick, GB). The FDA issued a Cleared decision on November 1, 2024 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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 Quanta Dialysis Technologies, Ltd. devices

Submission Details

510(k) Number K242269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2024
Decision Date November 01, 2024
Days to Decision 92 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
38d faster than avg
Panel avg: 130d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ONW Hemodialysis System For Home Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
Definition To Treat And Provide Hemodialysis Therapy At Home For Chronic Renal Failure Patients.
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.