Cleared Traditional

K862928 - AMUKIN-50% FOR CAPD Y-SET

K862928 is the FDA 510(k) clearance for AMUKIN-50% FOR CAPD Y-SET by Amuchina Intl., Inc.. It is a Class 2 Gastroenterology & Urology device (product code FKX) cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K862928 · Amuchina Intl., Inc. · Gastroenterology & Urology device
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Mar 1987
Decision
220d
Days
Class 2
Risk

K862928 is an FDA 510(k) clearance for the AMUKIN-50% FOR CAPD Y-SET. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Amuchina Intl., Inc. (Silver Spring, US). The FDA issued a Cleared decision on March 9, 1987 after a review of 220 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - 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 Amuchina Intl., Inc. devices

Submission Details

510(k) Number K862928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1986
Decision Date March 09, 1987
Days to Decision 220 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
90d slower than avg
Panel avg: 130d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FKX System, Peritoneal, Automatic Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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 - FKX System, Peritoneal, Automatic Delivery

All 46
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K862928.
PERITONEAL CATHETER STABILIZATION DEVICE 5C4381
K884554 · Baxter Healthcare Corp · Jan 1989
BENT NECK CURLCATH PERITONEAL DIALYSIS KIT
K874632 · Quinton, Inc. · Dec 1987
UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
K872652 · Travenol Laboratories, S.A. · Sep 1987
ABBOTT INPERSOL CYCLER 1000
K845042 · Abbott Laboratories · Mar 1985
ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM
K844630 · Organon Teknika Corp. · Mar 1985
AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM
K850406 · Travenol Laboratories, S.A. · Feb 1985