Cleared Traditional

K884725 - BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS

K884725 is an FDA 510(k) clearance for BIASOL POWDER CONCENTRATES FOR BICARB. ..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K884725 · Baxter Healthcare Corp · Gastroenterology & Urology device
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Jan 1989
Decision
81d
Days
Class 2
Risk

K884725 is an FDA 510(k) clearance for the BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on January 30, 1989 after a review of 81 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.

FDA 510(k) Submission Details - K884725

510(k) Number K884725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1988
Decision Date January 30, 1989
Days to Decision 81 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
50d faster than avg
Panel avg: 131d · This submission: 81d
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 123
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K884725.
BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE
K895199 · Baxter Healthcare Corp · Dec 1989
BICARBONATE CONCENTRATE POWDER
K891921 · Haemolyte, Inc. · Apr 1989
SODIUM BICARBONATE, U.S.P.
K891159 · Williams Medical Co. · Apr 1989
HEMODIALYSIS CONCENTRATES
K883068 · Dove Medical Supplies · Dec 1988
BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS
K880102 · Baxter Healthcare Corp · May 1988
HOSPAL DIALYSATE FOR C.A.V.H.D.
K872857 · Delmed, Inc. · Oct 1987
K884725 · BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS
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