510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K080650Substantially Equivalent

Omni-Dl System

Transvivo, Inc., Richmond CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080650 is the FDA 510(k) clearance record for OMNI-DL SYSTEM, a class II device, cleared for Transvivo, Inc. on under FDA product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System). FDA records list one 510(k) clearance for Transvivo, Inc. As of , FDA records show no recalls naming K080650.

Clearance record

Decision date
Received
(264 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
Transvivo, Inc. 3067 Research Dr., Richmond CA
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