Cleared Traditional

MICROSTAR VCI (K831766) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K831766 · Medionics International , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1983
Decision
135d
Days
Class 2
Risk

K831766 is an FDA 510(k) clearance for the MICROSTAR VCI. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Medionics International , Ltd. (Mchenry, US). The FDA issued a Cleared decision on October 14, 1983 after a review of 135 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 K831766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1983
Decision Date October 14, 1983
Days to Decision 135 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
5d slower than avg
Panel avg: 130d · This submission: 135d
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 32
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K831766.
EXTENDED LIFE CAPD SOLUTION TRANSFER
K840224 · Travenol Laboratories, S.A. · Feb 1984
CAPD ULTRAVIOLET GERMICIDAL EXCHANGE
K833595 · Travenol Laboratories, S.A. · Nov 1983
AUTOMATIC PERITONEAL DIALYSIS CYCLER
K833065 · Travenol Laboratories, S.A. · Nov 1983
ABBOTT PATIENT ASSIST DEVICE
K830766 · Abbott Laboratories · Mar 1983
STERILE, DISPOS. SPIKE PROTECTOR-5C4138
K823777 · Travenol Laboratories, S.A. · Jan 1983
INPERSOL PERITONEAL DIALSIS CYCLER SET
K823217 · Abbott Laboratories · Nov 1982