Cleared Traditional

K863631 - SODIUM BICARBONATE POWDER/BICARBONATE H...

K863631 is the FDA 510(k) clearance for SODIUM BICARBONATE POWDER/BICARBONATE H... by American Healthcare Corp.. It is a Class 2 Gastroenterology & Urology device (product code KPO) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K863631 · American Healthcare Corp. · Gastroenterology & Urology device
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Oct 1986
Decision
29d
Days
Class 2
Risk

K863631 is an FDA 510(k) clearance for the SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by American Healthcare Corp. (Longmont, US). The FDA issued a Cleared decision on October 16, 1986 after a review of 29 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 American Healthcare Corp. devices

Submission Details

510(k) Number K863631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1986
Decision Date October 16, 1986
Days to Decision 29 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
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 31
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K863631.
BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE
K895199 · Baxter Healthcare Corp · Dec 1989
BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS
K884725 · Baxter Healthcare Corp · Jan 1989
BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS
K880102 · Baxter Healthcare Corp · May 1988
DIALYSATE CONCENTRATE FOR HEMODIALYSIS
K810280 · Cobe Laboratories, Inc. · Feb 1981
LOW-ACETATE HEMODIALYSIS BATH CONCENTR.
K800624 · Travenol Laboratories, S.A. · Jul 1980
DRI-LYTE
K780353 · Mallinckrodt Critical Care · Apr 1978