510(k) · Cleared
ClearedCrit-Line Anemia Management Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hema Metrics, LLC · MSQ Test, Urea (Breath Or Blood)
Cleared on Sep 29, 2010 as substantially equivalent to K042566 (Vasc-Alert, Inc., 2004) after a 289-day review. Its family tree reaches back 4 generations to 1997. 3 later devices descend from it.
- Decided
- Sep 29, 2010
- Review
- 289 days
- Class
- Class I
- Product code
- MSQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K960817 (1997). 5 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK960817 HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)Transonic Systems, Inc. · 1997 · Recalled
- 3 generations backK980906 Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-COTransonic Systems, Inc. · 1998
- 2 generations backK030456 Vasc-AlertVasc-Alert, LLC · 2003
- 1 generation backK042566 Vasc-AlertVasc-Alert, Inc. · 2004
- This deviceK093834 Crit-Line Anemia Management SoftwareHema Metrics, LLC · 2010
- Descendant · cites it directly · 2 of its ownK130579 Physoft AmsPhysicians Software Systems, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK232283 PhySoftAMS®Physician Software Systems, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK180410 Dosis SAMDosis, Inc. · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960817 | HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2) | Transonic Systems, Inc. | 1997 | 1 |
| −3 | K980906 | Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO | Transonic Systems, Inc. | 1998 | — |
| −2 | K030456 | Vasc-Alert | Vasc-Alert, LLC | 2003 | — |
| −1 | K042566 | Vasc-Alert | Vasc-Alert, Inc. | 2004 | — |
| 0 (this device) | K093834 | Crit-Line Anemia Management Software | Hema Metrics, LLC | 2010 | — |
| +1 | K130579 | Physoft Ams | Physicians Software Systems, LLC | 2013 | — |
| +2 | K232283 | PhySoftAMS® | Physician Software Systems, LLC | 2023 | — |
| +2 | K180410 | Dosis SAM | Dosis, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MSQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSQ device
- #1 K220494 BreathID Hp Lab System, BreathID Smart Systemscore 8.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K010763 | FDA’s K010763 is Goodnet Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| * | K042566 | Vasc-AlertSummary page 2…monitoring software Classification Name System, hemodialysis, Access Recirculation Monitoring 51 0(k) K042566 Classification Regulations 876.5820 Product Code MQS 4. Intended Use The CL… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130579 | Physoft Ams | 2013 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K130579 (Physicians Software Systems, LLC, 2013) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MSQ devicesMSQ Test, Urea (Breath Or Blood): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MSQ
3in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MSQ
121in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSQ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSQ
1in 2025
MAUDE reports naming product code MSQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 2 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 3 | 121 | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093834 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093834: Crit-Line Anemia Management Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093834
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026