Cleared Traditional

K810600 - CAPD EXCHANGE SET

K810600 is the FDA 510(k) clearance for CAPD EXCHANGE SET by American Mcgaw. It is a Class 2 Gastroenterology & Urology device (product code KDJ) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K810600 · American Mcgaw · Gastroenterology & Urology device
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Mar 1981
Decision
18d
Days
Class 2
Risk

K810600 is an FDA 510(k) clearance for the CAPD EXCHANGE SET. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by American Mcgaw (Mchenry, US). The FDA issued a Cleared decision on March 24, 1981 after a review of 18 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 American Mcgaw devices

Submission Details

510(k) Number K810600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1981
Decision Date March 24, 1981
Days to Decision 18 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 130d · This submission: 18d
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 80
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K810600.
CARD U.V. GERMICIDAL CHAMBER II
K820546 · Travenol Laboratories, S.A. · Jun 1982
CAPD U.V. GERMICIDAL CONNECTION SYSTEM
K812802 · Travenol Laboratories, S.A. · Mar 1982
GAMBRO PERITONEAL DIALYSIS FLUID LINES
K811294 · Gambro, Inc. · Jun 1981
INPERSOL CAPD BAG PORT CLAMP
K803300 · Abbott Laboratories · Jan 1981
INPERSOL-CAPD ADMINISTRATION SET
K801881 · Abbott Laboratories · Oct 1980
INPERSOL CAPD ADMIN. SET & CATHETER ADAP
K800993 · Abbott Laboratories · Aug 1980