Cleared Traditional

K041792 - FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211

K041792 is an FDA 510(k) clearance for FRESENIUS STAYSAFE PATIENT CONNECTORS, manufactured by Fresenius Medical Care North America. The device is a Class 2 Gastroenterology & Urology device with product code KDJ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K041792 · Fresenius Medical Care North America · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
84d
Days
Class 2
Risk

K041792 is an FDA 510(k) clearance for the FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211. 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 September 24, 2004 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fresenius Medical Care North America devices

FDA 510(k) Submission Details - K041792

510(k) Number K041792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2004
Decision Date September 24, 2004
Days to Decision 84 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
47d faster than avg
Panel avg: 131d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDJ Device Classification - Class 2, Special Controls

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 100
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K041792.
APD LUER-LOCK ADAPTER
K124024 · Fresensius Medical Care North America · Sep 2013
FRESENIUS STERILE STAY SAFE CAP
K083542 · Fresenius Medical Care North America · Dec 2008
K.E.P. CONNECTOR AND CLIP
K042900 · K.E.P., LLC · Nov 2004
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
K031676 · Baxter Healthcare Corp · Nov 2003
FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
K022412 · Fresenius Medical Care North America · Mar 2003
PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE
K974387 · Microwave Medical Systems, Inc. · Sep 1999