Cleared Traditional

K864265 - HEMODIALYSIS BATH CONCENTRATE SOLUTIONS...

K864265 is an FDA 510(k) clearance for HEMODIALYSIS BATH CONCENTRATE SOLUTIONS..., manufactured by Dial Medical of Florida, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K864265 · Dial Medical of Florida, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1987
Decision
139d
Days
Class 2
Risk

K864265 is an FDA 510(k) clearance for the HEMODIALYSIS BATH CONCENTRATE SOLUTIONS FOR HEMODI. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Dial Medical of Florida, Inc. (Deland, US). The FDA issued a Cleared decision on March 17, 1987 after a review of 139 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 Dial Medical of Florida, Inc. devices

FDA 510(k) Submission Details - K864265

510(k) Number K864265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1986
Decision Date March 17, 1987
Days to Decision 139 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
9d slower than avg
Panel avg: 130d · This submission: 139d
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 53
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K864265.
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
HOSPAL DIALYSATE FOR CAVHD
K861156 · Hospal Medical Corp. · Sep 1986
CENTRALYTE BICARBONATE CONCENTRATE
K821304 · Erika, Inc. · May 1982
NATURALYTE BICARBONATE DIALYSATE CONCEN.
K810925 · Erika, Inc. · Apr 1981