# K903505: Bact/Alert (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Mar 12, 1991 after 221 days
- Product code: MDB (System, Blood Culturing)
- Device class: 1
- Regulation: 21 CFR 866.2560
- 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K161816: BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO (2017), 0 descendants of its own
- K973305: Bact/Alert Culture Bottles (1997), 0 descendants of its own

## Recalls of this device
- Dec 19, 2006 · Not classified · Z-0644-2007: Bottle data is not sent to BacT/ALERT 3D instrument.
- Aug 14, 2006 · Not classified · Z-0773-2007: Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.
- May 27, 2005 · Not classified · Z-0612-05: A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle.
- May 27, 2005 · Not classified · Z-0613-05: A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle.
- May 27, 2005 · Not classified · Z-0614-05: A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle.
- Sep 17, 2004 · Not classified · Z-0456-05: Over heating of memory board.

Source page: https://510kreport.com/device/K903505
Methodology: https://510kreport.com/methodology