510(k) · Cleared
ClearedVasc-Alert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vasc-Alert, LLC · KOC Accessories, Blood Circuit, Hemodialysis
Cleared on Jul 11, 2003 as substantially equivalent to K960817 (Transonic Systems, Inc., 1997) and 2 other predicates after a 150-day review. Its family tree reaches back 2 generations to 1997. 5 later devices descend from it.
- Decided
- Jul 11, 2003
- Review
- 150 days
- Class
- Class II
- Product code
- KOC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K960817 (1997). 3 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK960817 HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)Transonic Systems, Inc. · 1997 · Recalled
- 1 generation backK980906 Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-COTransonic Systems, Inc. · 1998
- This deviceK030456 Vasc-AlertVasc-Alert, LLC · 2003
- Descendant · cites it directly · 4 of its ownK042566 Vasc-AlertVasc-Alert, Inc. · 2004
- Descendant · 2 generations on · 3 of its ownK093834 Crit-Line Anemia Management SoftwareHema Metrics, LLC · 2010
- Descendant · 3 generations on · 2 of its ownK130579 Physoft AmsPhysicians Software Systems, LLC · 2013
- Descendant · 4 generations on · 0 of its ownK232283 PhySoftAMS®Physician Software Systems, LLC · 2023
- Descendant · 4 generations on · 0 of its ownK180410 Dosis SAMDosis, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K042566Vasc-AlertVasc-Alert, Inc. · 2004 · cites it directly4descendants
- K093834Crit-Line Anemia Management SoftwareHema Metrics, LLC · 2010 · 2 generations on3descendants
- K130579Physoft AmsPhysicians Software Systems, LLC · 2013 · 3 generations on2descendants
- K232283PhySoftAMS®Physician Software Systems, LLC · 2023 · 4 generations on0descendants
- K180410Dosis SAMDosis, Inc. · 2019 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960817 | HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2) | Transonic Systems, Inc. | 1997 | 1 |
| −1 | K980906 | Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO | Transonic Systems, Inc. | 1998 | — |
| 0 (this device) | K030456 | Vasc-Alert | Vasc-Alert, LLC | 2003 | — |
| +1 | K042566 | Vasc-Alert | Vasc-Alert, Inc. | 2004 | — |
| +2 | K093834 | Crit-Line Anemia Management Software | Hema Metrics, LLC | 2010 | — |
| +3 | K130579 | Physoft Ams | Physicians Software Systems, LLC | 2013 | — |
| +4 | K232283 | PhySoftAMS® | Physician Software Systems, LLC | 2023 | — |
| +4 | 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 |
|---|---|---|
| 2004 | 1 | 0 |
| 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 KOC? 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 KOC device
- #1 K230514 Blood Tubing Lines for Hemodialysis AL Series…score 11.8 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K960817 | HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)Summary page 1…Classification Name System, Hemodialysis, Access Recirculation Monitoring Equivalent Devices The Transonic HDOl Hemodialysis Monitor (K960817 and K980906), and Medisystems Access Alert (K002372). Device Description Vasc-Ale… | 1997 |
| * | K980906 | Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-COSummary page 1…fication Name System, Hemodialysis, Access Recirculation Monitoring Equivalent Devices The Transonic HDOl Hemodialysis Monitor (K960817 and K980906), and Medisystems Access Alert (K002372). Device Description Vasc-Alert is a soft… | 1998 |
| * | K002372 | Access Alert GaugeSummary page 1…ng Equivalent Devices The Transonic HDOl Hemodialysis Monitor (K960817 and K980906), and Medisystems Access Alert (K002372). Device Description Vasc-Alert is a software program for alerting dialysis center personnel of an increased risk of a… | 2000 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042566 | Vasc-Alert | 2004 | 4 |
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 6 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K042566 (Vasc-Alert, Inc., 2004) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K960817.
How does its category compare?
All KOC devicesKOC Accessories, Blood Circuit, Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KOC
Too few KOC 510(k)s in any year since 2007 to give a median.
Recalls per year · KOC
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KOC
50in 2025
MAUDE reports naming product code KOC, 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 | 1 | — | 0 | 3 |
| 2008 | 2 | — | 2 | 12 |
| 2009 | 2 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 1 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 22 |
| 2014 | 1 | — | 1 | 165 |
| 2015 | 2 | — | 0 | 555 |
| 2016 | 1 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 23 |
| 2018 | 0 | — | 3 | 37 |
| 2019 | 0 | — | 0 | 56 |
| 2020 | 1 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 33 |
| 2022 | 0 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 16 |
| 2024 | 0 | — | 0 | 18 |
| 2025 | 2 | — | 0 | 50 |
| 2026 | 0 | — | 4 | — |
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, as an aid for vascular access site management. The software is to be used with data generated from hemodialysis machines manufactured by Fresenius and Cobe/Gambro.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030456: 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/K030456
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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