Cleared Traditional

K822547 - CAPD BELT

K822547 is an FDA 510(k) clearance for CAPD BELT, manufactured by American Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKX cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K822547 · American Medical Products, Inc. · Gastroenterology & Urology device
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Sep 1982
Decision
16d
Days
Class 2
Risk

K822547 is an FDA 510(k) clearance for the CAPD BELT. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by American Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1982 after a review of 16 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 Medical Products, Inc. devices

FDA 510(k) Submission Details - K822547

510(k) Number K822547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1982
Decision Date September 09, 1982
Days to Decision 16 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
115d faster than avg
Panel avg: 131d · This submission: 16d
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 64
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K822547.
CCPD CYCLER SET W/5 PRONGED SAFE LOCK
K822549 · American Medical Products, Inc. · Oct 1982
SAFE LOCK TITANIUM ADAPTER SET
K822550 · American Medical Products, Inc. · Oct 1982
AUTOMATIC SPLICING DEVICE
K822025 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1982
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