# K050002: Vitek 2 Compact

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Feb 17, 2005 after 45 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K050150: Mani Needle & Suture Pack, Mani, Inc. (2005). Our reading of the summary gave K050150, which FDA decided on Dec 5, 2005, after this device was decided (Feb 17, 2005), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree.

## Most influential descendants
- K083536: Densichek Plus (2009), 2 descendants of its own
- K192110: Vitek Densichek (2019), 0 descendants of its own
- K093224: Densicheck Plus (2009), 0 descendants of its own

## Recalls of this device
- Jan 28, 2021 · Class II · Z-1307-2021: bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, the results in the VIT
- Jan 28, 2021 · Class II · Z-1308-2021: bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, the results in the VIT
- Nov 13, 2018 · Class II · Z-0639-2019: The VITEK 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the
- Jul 12, 2017 · Class II · Z-3075-2017: Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be process
- Jul 12, 2017 · Class II · Z-3076-2017: Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be process
- Feb 18, 2013 · Class II · Z-0991-2013: There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.

## Indications for use
The VITEK ® 2 Compact is intended to be used for the automated quantitative or qualitative susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae and S. pneumoniae.

Source page: https://510kreport.com/device/K050002
Methodology: https://510kreport.com/methodology