Cleared Traditional

K791676 - PERITONEAL DIALYSIS CYCLER MODEL PDC1000

K791676 is the FDA 510(k) clearance for PERITONEAL DIALYSIS CYCLER MODEL PDC1000 by J.M. Sounds Electronics Co.. It is a Class 2 Gastroenterology & Urology device (product code KPF) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K791676 · J.M. Sounds Electronics Co. · Gastroenterology & Urology device
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Dec 1979
Decision
101d
Days
Class 2
Risk

K791676 is an FDA 510(k) clearance for the PERITONEAL DIALYSIS CYCLER MODEL PDC1000. Classified as System, Dialysate Delivery, Semi-automatic, Peritoneal (product code KPF), Class II - Special Controls.

Submitted by J.M. Sounds Electronics Co. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1979 after a review of 101 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 J.M. Sounds Electronics Co. devices

Submission Details

510(k) Number K791676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1979
Decision Date December 06, 1979
Days to Decision 101 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
29d faster than avg
Panel avg: 130d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 8
Devices cleared under the same product code (KPF) and FDA review panel - the closest regulatory comparables to K791676.
ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE
K874020 · Abbott Laboratories · Jan 1988
GAMBRO PERITONEAL DIALYSIS MONITOR
K802831 · Gambro, Inc. · Dec 1980
CYCLER W/5 OR 10 HR. FILL/DWELL TIMER
K800496 · American Medical Products, Inc. · Jul 1980
CYLER/HEATER FOR PERITONEAL DIALYSIS
K791584 · American Medical Products, Inc. · Nov 1979
AMP AUTOMATIC CYCLER STAND
K790091 · American Medical Products, Inc. · Feb 1979