Cleared Traditional

K022412 - FRESENIUS CAPD STAY.SAFE DISPOSABLE ADM...

K022412 is the FDA 510(k) clearance for FRESENIUS CAPD STAY.SAFE DISPOSABLE ADM... by Fresenius Medical Care North America. It is a Class 2 Gastroenterology & Urology device (product code KDJ) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K022412 · Fresenius Medical Care North America · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2003
Decision
224d
Days
Class 2
Risk

K022412 is an FDA 510(k) clearance for the FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Fresenius Medical Care North America (Lexington, US). The FDA issued a Cleared decision on March 5, 2003 after a review of 224 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 K022412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2002
Decision Date March 05, 2003
Days to Decision 224 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
94d slower than avg
Panel avg: 130d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDJ Set, Administration, For Peritoneal Dialysis, Disposable
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 - KDJ Set, Administration, For Peritoneal Dialysis, Disposable

All 78
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K022412.
FRESENIUS STERILE STAY SAFE CAP
K083542 · Fresenius Medical Care North America · Dec 2008
FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211
K041792 · Fresenius Medical Care North America · Sep 2004
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
K031676 · Baxter Healthcare Corp · Nov 2003
HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE
K972579 · Baxter Healthcare Corp · Oct 1997
ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493
K961825 · Baxter Healthcare Corp · Aug 1996
RAPID DISCONNECT Y-SET, CAT. NO. 48-7000
K930843 · National Medical Care, Medical Products Div., Inc. · Aug 1994