510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K791676Substantially Equivalent

Peritoneal Dialysis Cycler Model Pdc1000

J.M. Sounds Electronics Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K791676 is the FDA 510(k) clearance record for PERITONEAL DIALYSIS CYCLER MODEL PDC1000, a class II device, cleared for J.M. Sounds Electronics Co. on under FDA product code KPF (System, Dialysate Delivery, Semi-Automatic, Peritoneal). FDA records list one 510(k) clearance for J.M. Sounds Electronics Co. As of , FDA records show no recalls naming K791676.

Clearance record

Decision date
Received
(101 days to decision)
Product code
KPF System, Dialysate Delivery, Semi-Automatic, Peritoneal
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
J.M. Sounds Electronics Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KPF

Trailing 12 months

FDA records hold no clearances under product code KPF in the trailing twelve months.

FDA records show no clearances under product code KPF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KPF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260