Cleared Traditional

K811706 - LACTIC ACID DIALYSATE ADDITIVE

K811706 is the FDA 510(k) clearance for LACTIC ACID DIALYSATE ADDITIVE by Edlaw Pharmaceuticals, Inc.. It is a Class 2 Chemistry device (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

Submission Details

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.

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 Chemistry devices follow this clearance model.

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

All 52
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K811706.
BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS
K880102 · Baxter Healthcare Corp · May 1988
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
DIALYSATE CONCENTRATE FOR HEMODIALYSIS
K810280 · Cobe Laboratories, Inc. · Feb 1981
LOW-ACETATE HEMODIALYSIS BATH CONCENTR.
K800624 · Travenol Laboratories, S.A. · Jul 1980