Cleared Traditional

K875121 - AMICON EQUALINE FLUID BALANCE SYSTEM

K875121 is the FDA 510(k) clearance for AMICON EQUALINE FLUID BALANCE SYSTEM by Amicon, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KPF) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K875121 · Amicon, Inc. · Gastroenterology & Urology device
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Feb 1988
Decision
66d
Days
Class 2
Risk

K875121 is an FDA 510(k) clearance for the AMICON EQUALINE FLUID BALANCE SYSTEM. Classified as System, Dialysate Delivery, Semi-automatic, Peritoneal (product code KPF), Class II - Special Controls.

Submitted by Amicon, Inc. (Danvers, US). The FDA issued a Cleared decision on February 19, 1988 after a review of 66 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 Amicon, Inc. devices

Submission Details

510(k) Number K875121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1987
Decision Date February 19, 1988
Days to Decision 66 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
64d faster than avg
Panel avg: 130d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPF System, Dialysate Delivery, Semi-automatic, Peritoneal
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 - KPF System, Dialysate Delivery, Semi-automatic, Peritoneal

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