Cleared Traditional

K871583 - MODIFIED LABELING FOR AMUKIN-50%

K871583 is the FDA 510(k) clearance for MODIFIED LABELING FOR AMUKIN-50% by Amuchina Intl., Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDJ) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K871583 · Amuchina Intl., Inc. · Gastroenterology & Urology device
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Jul 1987
Decision
77d
Days
Class 2
Risk

K871583 is an FDA 510(k) clearance for the MODIFIED LABELING FOR AMUKIN-50%. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Amuchina Intl., Inc. (Silver Spring, US). The FDA issued a Cleared decision on July 9, 1987 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Amuchina Intl., Inc. devices

Submission Details

510(k) Number K871583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1987
Decision Date July 09, 1987
Days to Decision 77 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
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDJ Set, Administration, For Peritoneal Dialysis, Disposable
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 - KDJ Set, Administration, For Peritoneal Dialysis, Disposable

All 79
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K871583.
EXTENDED LIFE CAPD SOLUTION TRANSFER SET IC4373
K882455 · Baxter Healthcare Corp · Jul 1988
EXTENDED LIFE CAPD TRANSFER SET 5C4444
K882498 · Baxter Healthcare Corp · Jul 1988
AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)
K873984 · Travenol Laboratories, S.A. · Oct 1987
CAPD Y-ADMIN. SET USED W/INPERSOL BIOCAP ADMIN.
K871049 · Abbott Laboratories · Apr 1987
CAPD ADMIN. SET USED W/INPERSOL CAPD BIOCAP Y-ADM.
K871050 · Abbott Laboratories · Apr 1987
EXTERNAL Y VALVE 5C4198
K870145 · Travenol Laboratories, S.A. · Mar 1987