Cleared Traditional

K910270 - PREMIXED DIALYSATE FOR HEMODIAFILTRATION

K910270 is the FDA 510(k) clearance for PREMIXED DIALYSATE FOR HEMODIAFILTRATION by Baxter Healthcare Corp. It is a Class 2 Gastroenterology & Urology device (product code KPO) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K910270 · Baxter Healthcare Corp · Gastroenterology & Urology device
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Apr 1991
Decision
85d
Days
Class 2
Risk

K910270 is an FDA 510(k) clearance for the PREMIXED DIALYSATE FOR HEMODIAFILTRATION. 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 April 18, 1991 after a review of 85 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 K910270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1991
Decision Date April 18, 1991
Days to Decision 85 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
45d faster than avg
Panel avg: 130d · This submission: 85d
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 51
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K910270.
HEMODIALYSIS BATH
K922990 · Medi-Tech, Inc. · Sep 1994
GRANULYTE DIALYSATE CONCENTRATE
K922005 · Fresenius USA, Inc. · Mar 1994
GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING
K911459 · Fresenius USA, Inc. · Jul 1991
ACETATE CONCENTRATES FOR HEMODIALYSIS
K905021 · Medical Components, Inc. · Mar 1991
FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB
K896111 · Fresenius USA, Inc. · Dec 1989
BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE
K895199 · Baxter Healthcare Corp · Dec 1989