Cleared Traditional

K861156 - HOSPAL DIALYSATE FOR CAVHD

K861156 is an FDA 510(k) clearance for HOSPAL DIALYSATE FOR CAVHD, manufactured by Hospal Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K861156 · Hospal Medical Corp. · Gastroenterology & Urology device
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Sep 1986
Decision
179d
Days
Class 2
Risk

K861156 is an FDA 510(k) clearance for the HOSPAL DIALYSATE FOR CAVHD. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Hospal Medical Corp. (East Brunswick, US). The FDA issued a Cleared decision on September 23, 1986 after a review of 179 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 Hospal Medical Corp. devices

FDA 510(k) Submission Details - K861156

510(k) Number K861156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1986
Decision Date September 23, 1986
Days to Decision 179 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
48d slower than avg
Panel avg: 131d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPO Device Classification - Class 2, Special Controls

Product Code KPO Dialysate Concentrate For Hemodialysis (liquid Or Powder)
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 - KPO Dialysate Concentrate For Hemodialysis (liquid Or Powder)

All 80
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K861156.
BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS
K884725 · Baxter Healthcare Corp · Jan 1989
BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS
K880102 · Baxter Healthcare Corp · May 1988
HOSPAL DIALYSATE FOR C.A.V.H.D.
K872857 · Delmed, Inc. · Oct 1987
ULTRACLONE 05-100 GUINEA PIG RBC
K854206 · Earl-Clay Laboratories, Inc. · Oct 1985
CENTRALYTE BICARBONATE CONCENTRATE
K821304 · Erika, Inc. · May 1982
NATURALYTE BICARBONATE DIALYSATE CONCEN.
K810925 · Erika, Inc. · Apr 1981