Cleared Traditional

K801220 - PERITONEAL DIALYSIS CYCLER SET W/PUMP

K801220 is the FDA 510(k) clearance for PERITONEAL DIALYSIS CYCLER SET W/PUMP by American Medical Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDJ) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K801220 · American Medical Products, Inc. · Gastroenterology & Urology device
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Aug 1980
Decision
82d
Days
Class 2
Risk

K801220 is an FDA 510(k) clearance for the PERITONEAL DIALYSIS CYCLER SET W/PUMP. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by American Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1980 after a review of 82 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

Submission Details

510(k) Number K801220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1980
Decision Date August 12, 1980
Days to Decision 82 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
48d faster than avg
Panel avg: 130d · This submission: 82d
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 79
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K801220.
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
CONTINUOUS AMBULATORY DIALYSIS (CAPD)
K791512 · Norton Performance Plastics Corp. · Feb 1980
CAPD TRANSFER SET JC9044
K792651 · Travenol Laboratories, S.A. · Feb 1980
CYCLER SETS MOD. #5C4143, 5C4144, 5C4145
K791899 · Travenol Laboratories, S.A. · Nov 1979