Cleared Traditional

K861730 - ACTRIL FOR KIDNEY MACHINE DISINFECTANT

K861730 is the FDA 510(k) clearance for ACTRIL FOR KIDNEY MACHINE DISINFECTANT by Renal Systems, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FKQ) cleared through the Traditional 510(k) pathway after a 399-day FDA review.

K861730 · Renal Systems, Inc. · Gastroenterology & Urology device
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Jun 1987
Decision
399d
Days
Class 2
Risk

K861730 is an FDA 510(k) clearance for the ACTRIL FOR KIDNEY MACHINE DISINFECTANT. Classified as System, Dialysate Delivery, Central Multiple Patient (product code FKQ), Class II - Special Controls.

Submitted by Renal Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 9, 1987 after a review of 399 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 Renal Systems, Inc. devices

Submission Details

510(k) Number K861730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1986
Decision Date June 09, 1987
Days to Decision 399 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
269d slower than avg
Panel avg: 130d · This submission: 399d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FKQ System, Dialysate Delivery, Central Multiple Patient
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 - FKQ System, Dialysate Delivery, Central Multiple Patient

All 31
Devices cleared under the same product code (FKQ) and FDA review panel - the closest regulatory comparables to K861730.
TWO TANK DISSOLUTION MODULE
K893612 · National Medical Care, Medical Products Div., Inc. · Jul 1989
MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM
K874084 · National Medical Care, Medical Products Div., Inc. · Apr 1988
FOUR TANK DISSOLUTION MODULE
K864635 · National Medical Care, Medical Products Div., Inc. · Jan 1987
MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445
K861472 · National Medical Care, Medical Products Div., Inc. · Jul 1986
NATURALYTE BICARBONATE CONCENTRATE-DRY PACK
K852310 · Erika, Inc. · Jul 1985
NEPHROSS ALLEGRO H.F.
K844748 · Organon Teknika Corp. · Jan 1985