510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083158Substantially Equivalent

Exalis, Software Version 1.15

Gambro, Inc., Denver CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083158 is the FDA 510(k) clearance record for EXALIS, SOFTWARE VERSION 1.15, a class II device, cleared for Gambro, Inc. on under FDA product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System). FDA records list 87 510(k) clearances for Gambro, Inc., from to . As of , FDA records show no recalls naming K083158.

Clearance record

Decision date
Received
(224 days to decision)
Product code
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation
21 CFR 876.5860
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Gambro, Inc. 14143 Denver W. Pkwy., Denver CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KDI

Trailing 12 months
6 clearances under product code KDI in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KDI, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20261
March 20261
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260