Cleared Traditional

K845041 - CAPD STAGED CONNECTOR

K845041 is an FDA 510(k) clearance for CAPD STAGED CONNECTOR, manufactured by Abbott Laboratories. The device is a Class 2 Gastroenterology & Urology device with product code FKO cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K845041 · Abbott Laboratories · Gastroenterology & Urology device
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Feb 1985
Decision
55d
Days
Class 2
Risk

K845041 is an FDA 510(k) clearance for the CAPD STAGED CONNECTOR. Classified as Catheter, Peritoneal Dialysis, Single Use (product code FKO), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 21, 1985 after a review of 55 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K845041

510(k) Number K845041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1984
Decision Date February 21, 1985
Days to Decision 55 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 130d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKO Device Classification - Class 2, Special Controls

Product Code FKO Catheter, Peritoneal Dialysis, Single Use
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 - FKO Catheter, Peritoneal Dialysis, Single Use

All 10
Devices cleared under the same product code (FKO) and FDA review panel - the closest regulatory comparables to K845041.
MODIFIED USE OF PULL-APART INTRODUCER SET
K871730 · Quinton, Inc. · May 1987
ACUTE PERITONEAL DIALYSIS KIT
K870472 · Quinton, Inc. · Feb 1987
PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8
K860155 · Medical Components, Inc. · Feb 1986
LAZARUS-NELSON PERITONEAL LAVAGE TRAY
K813336 · American Pharmaseal Div. Ahsc · Dec 1981
NON-STERILE SHADOW-STRIPE CATHETER
K812717 · Quinton, Inc. · Oct 1981
QUINTON CATHETER FINGER GRIP
K811266 · Quinton, Inc. · Jun 1981