Cleared Traditional

K800496 - CYCLER W/5 OR 10 HR. FILL/DWELL TIMER

K800496 is an FDA 510(k) clearance for CYCLER W/5 OR 10 HR. FILL/DWELL TIMER, manufactured by American Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPF cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K800496 · American Medical Products, Inc. · Gastroenterology & Urology device
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Jul 1980
Decision
139d
Days
Class 2
Risk

K800496 is an FDA 510(k) clearance for the CYCLER W/5 OR 10 HR. FILL/DWELL TIMER. Classified as System, Dialysate Delivery, Semi-automatic, Peritoneal (product code KPF), Class II - Special Controls.

Submitted by American Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1980 after a review of 139 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Medical Products, Inc. devices

FDA 510(k) Submission Details - K800496

510(k) Number K800496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1980
Decision Date July 21, 1980
Days to Decision 139 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
8d slower than avg
Panel avg: 131d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPF Device Classification - Class 2, Special Controls

Product Code KPF System, Dialysate Delivery, Semi-automatic, Peritoneal
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 - KPF System, Dialysate Delivery, Semi-automatic, Peritoneal

All 9
Devices cleared under the same product code (KPF) and FDA review panel - the closest regulatory comparables to K800496.
AMICON EQUALINE FLUID BALANCE SYSTEM
K875121 · Amicon, Inc. · Feb 1988
ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE
K874020 · Abbott Laboratories · Jan 1988
GAMBRO PERITONEAL DIALYSIS MONITOR
K802831 · Gambro, Inc. · Dec 1980
CYLER/HEATER FOR PERITONEAL DIALYSIS
K791584 · American Medical Products, Inc. · Nov 1979
AMP AUTOMATIC CYCLER STAND
K790091 · American Medical Products, Inc. · Feb 1979