510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161816Substantially Equivalent

BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO

bioMerieux, Inc., Hazelwood MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161816 is the FDA 510(k) clearance record for BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO, a class I device, cleared for bioMerieux, Inc. on under FDA product code MDB (System, Blood Culturing). FDA records list 408 510(k) clearances for bioMerieux, Inc., from to . As of , FDA records show no recalls naming K161816.

Clearance record

Decision date
Received
(270 days to decision)
Product code
MDB System, Blood Culturing
Regulation
21 CFR 866.2560
Device class
Class I
Review panel
Microbiology
Applicant
bioMerieux, Inc. 595 Anglum Rd., Hazelwood MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MDB

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