Cleared Traditional

K895199 - BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE

K895199 is an FDA 510(k) clearance for BIASOL LIQUID CONCENTRATES, 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 117-day FDA review.

K895199 · Baxter Healthcare Corp · Gastroenterology & Urology device
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Dec 1989
Decision
117d
Days
Class 2
Risk

K895199 is an FDA 510(k) clearance for the BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE. 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 December 13, 1989 after a review of 117 days - within the typical 510(k) review window.

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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K895199

510(k) Number K895199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1989
Decision Date December 13, 1989
Days to Decision 117 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
14d faster than avg
Panel avg: 131d · This submission: 117d
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 K895199.
PREMIXED DIALYSATE FOR HEMODIAFILTRATION
K910270 · Baxter Healthcare Corp · Apr 1991
ACETATE CONCENTRATES FOR HEMODIALYSIS
K905021 · Medical Components, Inc. · Mar 1991
FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB
K896111 · Fresenius USA, Inc. · 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
HOSPAL DIALYSATE FOR C.A.V.H.D.
K872857 · Delmed, Inc. · Oct 1987