510(k) · Cleared
ClearedVasc-Alert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vasc-Alert, Inc. · MQS System, Hemodialysis, Access Recirculation Monitoring
Cleared on Nov 8, 2004 as substantially equivalent to K030456 (Vasc-Alert, LLC, 2003) after a 48-day review. Its family tree reaches back 3 generations to 1997. 4 later devices descend from it.
- Decided
- Nov 8, 2004
- Review
- 48 days
- Class
- Class II
- Product code
- MQS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K960817 (1997). 4 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK960817 HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)Transonic Systems, Inc. · 1997 · Recalled
- 2 generations backK980906 Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-COTransonic Systems, Inc. · 1998
- 1 generation backK030456 Vasc-AlertVasc-Alert, LLC · 2003
- This deviceK042566 Vasc-AlertVasc-Alert, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK093834 Crit-Line Anemia Management SoftwareHema Metrics, LLC · 2010
- Descendant · 2 generations on · 2 of its ownK130579 Physoft AmsPhysicians Software Systems, LLC · 2013
- Descendant · 3 generations on · 0 of its ownK232283 PhySoftAMS®Physician Software Systems, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK180410 Dosis SAMDosis, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K093834Crit-Line Anemia Management SoftwareHema Metrics, LLC · 2010 · cites it directly3descendants
- K130579Physoft AmsPhysicians Software Systems, LLC · 2013 · 2 generations on2descendants
- K232283PhySoftAMS®Physician Software Systems, LLC · 2023 · 3 generations on0descendants
- K180410Dosis SAMDosis, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960817 | HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2) | Transonic Systems, Inc. | 1997 | 1 |
| −2 | K980906 | Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO | Transonic Systems, Inc. | 1998 | — |
| −1 | K030456 | Vasc-Alert | Vasc-Alert, LLC | 2003 | — |
| 0 (this device) | K042566 | Vasc-Alert | Vasc-Alert, Inc. | 2004 | — |
| +1 | K093834 | Crit-Line Anemia Management Software | Hema Metrics, LLC | 2010 | — |
| +2 | K130579 | Physoft Ams | Physicians Software Systems, LLC | 2013 | — |
| +3 | K232283 | PhySoftAMS® | Physician Software Systems, LLC | 2023 | — |
| +3 | 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 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 MQS? 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 MQS device
- #1 K232283 PhySoftAMS®score 8.0 · 6 generations · no Class I recall
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030456 | Vasc-AlertSummary page 1…cess site patency monitoring software Classification Name System, Hemodialysis, Access Recirculation Monitoring Equivalent Devices Vasc-Alert (K030456) Device Description Vase-Alert is a software program for alerting dialysis center personnel of an increased risk of access sit… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093834 | Crit-Line Anemia Management Software | 2010 | 3 |
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 7 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K093834 (Hema Metrics, LLC, 2010) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MQS devicesMQS System, Hemodialysis, Access Recirculation Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQS
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MQS
Too few MQS 510(k)s in any year since 2007 to give a median.
Recalls per year · MQS
No recall names MQS since 2007.
Adverse event reports per year · MQS
5in 2013
MAUDE reports naming product code MQS, 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 | — | 0 | 68 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Vasc-Alert vascular data analysis software is intended for use by Healthcare professionals in a non-critical care setting for assessment of increased risk of access site stenosis in patients with grafts and fistulas, as an aid for vascular access site management. The software is to be used with data generated from hemodialysis machines.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042566: Vasc-Alert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042566
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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