Cleared Traditional

K811706 - LACTIC ACID DIALYSATE ADDITIVE

K811706 is an FDA 510(k) clearance for LACTIC ACID DIALYSATE ADDITIVE, manufactured by Edlaw Pharmaceuticals, Inc.. The device is a Class 2 Chemistry device with product code KPO cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K811706 · Edlaw Pharmaceuticals, Inc. · Chemistry device
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Sep 1981
Decision
100d
Days
Class 2
Risk

K811706 is an FDA 510(k) clearance for the LACTIC ACID DIALYSATE ADDITIVE. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Edlaw Pharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 24, 1981 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 876.5820 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Edlaw Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K811706

510(k) Number K811706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1981
Decision Date September 24, 1981
Days to Decision 100 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 88d · This submission: 100d
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 Chemistry devices follow this clearance model.

Regulatory Peers - KPO Dialysate Concentrate For Hemodialysis (liquid Or Powder)

All 82
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K811706.
HOSPAL DIALYSATE FOR CAVHD
K861156 · Hospal Medical Corp. · Sep 1986
ULTRACLONE 05-100 GUINEA PIG RBC
K854206 · Earl-Clay Laboratories, Inc. · Oct 1985
CENTRALYTE BICARBONATE CONCENTRATE
K821304 · Erika, Inc. · May 1982
NATURALYTE BICARBONATE DIALYSATE CONCEN.
K810925 · Erika, Inc. · Apr 1981
DIALYSATE CONCENTRATE FOR HEMODIALYSIS
K810280 · Cobe Laboratories, Inc. · Feb 1981
LOW-ACETATE HEMODIALYSIS BATH CONCENTR.
K800624 · Travenol Laboratories, S.A. · Jul 1980