# K093834: Crit-Line Anemia Management Software

- Pathway: 510(k) (Traditional)
- Applicant: Hema Metrics, LLC
- Decided: Sep 29, 2010 after 289 days
- Product code: MSQ (Test, Urea (Breath Or Blood))
- Device class: 1
- Regulation: 21 CFR 866.3110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K960817 (1997). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042566: Vasc-Alert, Vasc-Alert, Inc. (2004) Summary page 2.

## Cited in the summary but kept off the family tree
- K010763: Goodnet, Goodman Co., Ltd. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K130579: Physoft Ams (2013), 2 descendants of its own
- K232283: PhySoftAMS® (2023), 0 descendants of its own
- K180410: Dosis SAM (2019), 0 descendants of its own

## Indications for use
The Crit-Line Anemia Management software is a database application used to record, track and trend patient data as pertains to the management of anemia, and provide 6 dosage recommendation.

Source page: https://510kreport.com/device/K093834
Methodology: https://510kreport.com/methodology