Cleared Traditional

K823839 - AMPCO KIDNEY DIALYSIS TRAY

K823839 is an FDA 510(k) clearance for AMPCO KIDNEY DIALYSIS TRAY, manufactured by Associated Medical Products Co.. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K823839 · Associated Medical Products Co. · Gastroenterology & Urology device
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Mar 1983
Decision
98d
Days
Class 2
Risk

K823839 is an FDA 510(k) clearance for the AMPCO KIDNEY DIALYSIS TRAY. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Associated Medical Products Co. (Walker, US). The FDA issued a Cleared decision on March 29, 1983 after a review of 98 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 Associated Medical Products Co. devices

FDA 510(k) Submission Details - K823839

510(k) Number K823839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1982
Decision Date March 29, 1983
Days to Decision 98 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
32d faster than avg
Panel avg: 130d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOC Device Classification - Class 2, Special Controls

Product Code KOC Accessories, Blood Circuit, Hemodialysis
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 122
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K823839.
EXTRASENSR ULTRAFILTRATION MONITOR
K831433 · Extracorporeal Medical Specialities, Inc. · Jun 1983
LUNDIA 10-3-L PARALLEL FLOW DIALYZER
K831338 · Gambro, Inc. · May 1983
LUNDIA 10-2-N PARALLEL FLOW DIALYZER
K830905 · Gambro, Inc. · Apr 1983
C-DAK ARTIFICIAL KIDNEY
K830729 · Cordis Corp. · Mar 1983
KF-101-07 DIALYZER
K822337 · Extracorporeal Medical Specialities, Inc. · Feb 1983
KF-101-10 DIALYZER
K822338 · Extracorporeal Medical Specialities, Inc. · Feb 1983