DeviceClearance

MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X— 510(k) K131202

Substantially Equivalent

Dialysis Medical Solutions, LLC

FDA 510(k) clearance K131202 for MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X, Substantially Equivalent on 2014-04-03. Applicant: Dialysis Medical Solutions, LLC. Device class: 2.

Clearance details

Applicant
Dialysis Medical Solutions, LLC
Product code
Code KPO
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Columbus, OH, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code KPO

view all

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 →

Recalls naming K131202

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131202.

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