Cleared Traditional

K880459 - 480 HIGH-FLOW ULTRAFILTRATION CONTROL D...

K880459 is the FDA 510(k) clearance for 480 HIGH-FLOW ULTRAFILTRATION CONTROL D... by Cd Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FKP) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K880459 · Cd Medical, Inc. · Gastroenterology & Urology device
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Apr 1988
Decision
70d
Days
Class 2
Risk

K880459 is an FDA 510(k) clearance for the 480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE. Classified as System, Dialysate Delivery, Single Patient (product code FKP), Class II - Special Controls.

Submitted by Cd Medical, Inc. (Miami Lakes, US). The FDA issued a Cleared decision on April 13, 1988 after a review of 70 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cd Medical, Inc. devices

Submission Details

510(k) Number K880459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1988
Decision Date April 13, 1988
Days to Decision 70 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
60d faster than avg
Panel avg: 130d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K880459.
HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB
K894838 · Baxter Healthcare Corp · Sep 1989
FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM
K890824 · Fresenius USA, Inc. · May 1989
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