Cleared Traditional

K002892 - FRSENIUS PD IQCARD CYCLER

K002892 is the FDA 510(k) clearance for FRSENIUS PD IQCARD CYCLER by Fresenius Medical Care North America. It is a Class 2 Gastroenterology & Urology device (product code FKX) cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K002892 · Fresenius Medical Care North America · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
202d
Days
Class 2
Risk

K002892 is an FDA 510(k) clearance for the FRSENIUS PD IQCARD CYCLER. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Fresenius Medical Care North America (Lexington, US). The FDA issued a Cleared decision on April 5, 2001 after a review of 202 days - an extended review 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: 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 Fresenius Medical Care North America devices

Submission Details

510(k) Number K002892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2000
Decision Date April 05, 2001
Days to Decision 202 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 130d · This submission: 202d
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 45
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K002892.
HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310
K053512 · Baxter Healthcare Corp · Feb 2006
FRESENIUS LIBERTY CYCLER
K043363 · Fresenius Medical Care North America · Mar 2005
HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
K012988 · Baxter Healthcare Corp · Dec 2001
BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST
K935659 · Baxter Healthcare Corp · Jul 1994
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