Cleared Traditional

K910173 - SELECTRA AND TUBING SETS

K910173 is an FDA 510(k) clearance for SELECTRA AND TUBING SETS, manufactured by Medionics International , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FKX cleared through the Traditional 510(k) pathway after a 363-day FDA review.

K910173 · Medionics International , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
363d
Days
Class 2
Risk

K910173 is an FDA 510(k) clearance for the SELECTRA AND TUBING SETS. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Medionics International , Ltd. (Canada L6e 1a5, CA). The FDA issued a Cleared decision on January 13, 1992 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

FDA 510(k) Submission Details - K910173

510(k) Number K910173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1991
Decision Date January 13, 1992
Days to Decision 363 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
232d slower than avg
Panel avg: 131d · This submission: 363d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKX Device Classification - Class 2, Special Controls

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 66
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K910173.
BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL
K923065 · Baxter Healthcare Corp · Mar 1994
R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260
K933687 · R & D Batteries, Inc. · Feb 1994
NMC CYCLER MACHINE
K905809 · National Medical Care, Medical Products Div., Inc. · Feb 1992
DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION
K901477 · Delmed, Inc. · Jul 1990
DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION
K901478 · Delmed, Inc. · Jul 1990
ABBOTT INPERSOL CYCLER 1000
K895336 · Abbott Laboratories · Nov 1989