Cleared Traditional

K863609 - SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22

K863609 is an FDA 510(k) clearance for SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT ..., manufactured by International Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKP cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K863609 · International Medical Products, Inc. · Gastroenterology & Urology device
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Feb 1987
Decision
162d
Days
Class 2
Risk

K863609 is an FDA 510(k) clearance for the SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22. Classified as System, Dialysate Delivery, Single Patient (product code FKP), Class II - Special Controls.

Submitted by International Medical Products, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 25, 1987 after a review of 162 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 International Medical Products, Inc. devices

FDA 510(k) Submission Details - K863609

510(k) Number K863609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1986
Decision Date February 25, 1987
Days to Decision 162 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 131d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKP Device Classification - Class 2, Special Controls

Product Code FKP System, Dialysate Delivery, Single 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 - FKP System, Dialysate Delivery, Single Patient

All 37
Devices cleared under the same product code (FKP) and FDA review panel - the closest regulatory comparables to K863609.
HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650
K883111 · Baxter Healthcare Corp · Feb 1989
GAMBRO BICART SYSTEM
K873155 · Gambro, Inc. · Oct 1987
MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT
K871218 · Hospal Medical Corp. · Apr 1987
GAMBRO FLUID CONTROL MONITOR FCM 10-1
K864094 · Gambro, Inc. · Nov 1986
GAMBRO BICARBONATE MONITOR BCM 10-2
K864083 · Gambro, Inc. · Nov 1986
MONITRAL S
K861230 · Hospal Medical Corp. · Apr 1986