Cleared Traditional

K831716 - CAPD - CATHETER ADAPTER

K831716 is an FDA 510(k) clearance for CAPD - CATHETER ADAPTER, manufactured by American Mcgaw. The device is a Class 2 Gastroenterology & Urology device with product code FKX cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K831716 · American Mcgaw · Gastroenterology & Urology device
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Jun 1983
Decision
28d
Days
Class 2
Risk

K831716 is an FDA 510(k) clearance for the CAPD - CATHETER ADAPTER. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by American Mcgaw (Mchenry, US). The FDA issued a Cleared decision on June 24, 1983 after a review of 28 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

FDA 510(k) Submission Details - K831716

510(k) Number K831716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1983
Decision Date June 24, 1983
Days to Decision 28 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
103d faster than avg
Panel avg: 131d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKX Device Classification - Class 2, Special Controls

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 65
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K831716.
PERITONEAL CATHETER-CHANGES-
K833749 · Quinton, Inc. · Dec 1983
CAPD ULTRAVIOLET GERMICIDAL EXCHANGE
K833595 · Travenol Laboratories, S.A. · Nov 1983
AUTOMATIC PERITONEAL DIALYSIS CYCLER
K833065 · Travenol Laboratories, S.A. · Nov 1983
AMPERCIDE DISINFECTANT ACCESSORY TO -
K830881 · American Medical Products, Inc. · Jun 1983
EMPTY DIALYSATE CONTAINER BB-69
K830689 · Delmed, Inc. · Mar 1983
ABBOTT PATIENT ASSIST DEVICE
K830766 · Abbott Laboratories · Mar 1983