Cleared Traditional

K810683 - CAPD CATHETER ADAPTER

K810683 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 56-day FDA review.

K810683 · American Mcgaw · Gastroenterology & Urology device
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May 1981
Decision
56d
Days
Class 2
Risk

K810683 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 May 8, 1981 after a review of 56 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 - K810683

510(k) Number K810683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1981
Decision Date May 08, 1981
Days to Decision 56 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
75d faster than avg
Panel avg: 131d · This submission: 56d
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 K810683.
DIANEAL SOLUTION EXCHANGE DEVICE #5C4193
K822361 · Travenol Laboratories, S.A. · Aug 1982
ERIKA CAPD PREP KIT #30-9501-5
K820179 · Erika, Inc. · Feb 1982
THE AMP 80/2 PEDIATRIC CYCLER SYSTEM
K811986 · American Medical Products, Inc. · Aug 1981
ADR-10600(ADR 400),10601 (ADR 300)
K791342 · Physio-Control Corp. · Nov 1979
DIALYSIS DRAINAGE UNIT, PERITONEAL
K772150 · C.R. Bard, Inc. · Nov 1977
RINSE BLOCK ASSEM, D-W PERI. DIALYSIS
K771484 · Quinton, Inc. · Oct 1977