DeviceClearance

Product code KPO— Gastroenterology, Urology

Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate

Classification name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Total cleared
124
First cleared
Most recent

Market context for product code KPO

FDA has cleared 124 devices under product code KPO between 1978 and 2026, filed by 68 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code KPO

Adverse events under product code KPO

product code KPO
Death
14
Malfunction
775
Other
20
Total
809

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code KPO

1–100 of 124

Data sourced from openFDA. This site is unofficial and independent of the FDA.