Cleared Traditional

K832141 - MICROSTAR VC1 VOLUMETRIC CYCLER

K832141 is the FDA 510(k) clearance for MICROSTAR VC1 VOLUMETRIC CYCLER by Medionics International , Ltd.. It is a Class 2 Gastroenterology & Urology device (product code FKX) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K832141 · Medionics International , Ltd. · Gastroenterology & Urology device
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Oct 1983
Decision
101d
Days
Class 2
Risk

K832141 is an FDA 510(k) clearance for the MICROSTAR VC1 VOLUMETRIC CYCLER. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Medionics International , Ltd. (Walker, US). The FDA issued a Cleared decision on October 14, 1983 after a review of 101 days - within the typical 510(k) review window.

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 Medionics International , Ltd. devices

Submission Details

510(k) Number K832141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1983
Decision Date October 14, 1983
Days to Decision 101 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
29d faster than avg
Panel avg: 130d · This submission: 101d
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 58
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K832141.
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AUTOMATIC PERITONEAL DIALYSIS CYCLER
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AMPERCIDE DISINFECTANT ACCESSORY TO -
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