Cleared Traditional

K894838 - HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS...

K894838 is the FDA 510(k) clearance for HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS... by Baxter Healthcare Corp. It is a Class 2 Gastroenterology & Urology device (product code FKP) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K894838 · Baxter Healthcare Corp · Gastroenterology & Urology device
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Sep 1989
Decision
38d
Days
Class 2
Risk

K894838 is an FDA 510(k) clearance for the HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB. Classified as System, Dialysate Delivery, Single Patient (product code FKP), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on September 7, 1989 after a review of 38 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K894838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1989
Decision Date September 07, 1989
Days to Decision 38 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
92d faster than avg
Panel avg: 130d · This submission: 38d
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 36
Devices cleared under the same product code (FKP) and FDA review panel - the closest regulatory comparables to K894838.
COBE CENTRYSYSTEM 3 BICART OPTION KIT
K905388 · Cobe Laboratories, Inc. · Feb 1991
GAMBRO BICARBONATE MONITOR BCM 10-3
K896758 · Gambro, Inc. · Sep 1990
GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS
K896757 · Gambro, Inc. · Aug 1990
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