Cleared Traditional

K970989 - CYBERREN

K970989 is an FDA 510(k) clearance for CYBERREN, manufactured by Cybernius Medical , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KPF cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K970989 · Cybernius Medical , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
128d
Days
Class 2
Risk

K970989 is an FDA 510(k) clearance for the CYBERREN. Classified as System, Dialysate Delivery, Semi-automatic, Peritoneal (product code KPF), Class II - Special Controls.

Submitted by Cybernius Medical , Ltd. (St. Albert, Alberta, CA). The FDA issued a Cleared decision on July 24, 1997 after a review of 128 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 Cybernius Medical , Ltd. devices

FDA 510(k) Submission Details - K970989

510(k) Number K970989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1997
Decision Date July 24, 1997
Days to Decision 128 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 130d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPF Device Classification - Class 2, Special Controls

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

All 8
Devices cleared under the same product code (KPF) and FDA review panel - the closest regulatory comparables to K970989.
RENALSOFT
K061515 · Baxter Healthcare Corp · Sep 2006
RENAL LINK
K990953 · Baxter Healthcare Corp · Jun 1999
PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
K955762 · Fresenius USA, Inc. · Jul 1996
ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE
K874020 · Abbott Laboratories · Jan 1988
GAMBRO PERITONEAL DIALYSIS MONITOR
K802831 · Gambro, Inc. · Dec 1980
CYCLER W/5 OR 10 HR. FILL/DWELL TIMER
K800496 · American Medical Products, Inc. · Jul 1980