510(k) · Cleared
Recalled · 2005Vascular Assist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huntleigh Healthcare, Inc. · DPW Flowmeter, Blood, Cardiovascular
Cleared on May 2, 2001 after a 286-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it. It has been recalled once.
- Decided
- May 2, 2001
- Review
- 286 days
- Class
- Class II
- Product code
- DPW
- Recalls
- 1
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK002186 Vascular AssistHuntleigh Healthcare, Inc. · 2001
- Descendant · cites it directly · 5 of its ownK183574 SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes…Huntleigh Healthcare, Ltd. · 2019
- Descendant · cites it directly · 5 of its ownK121108 Dopplex AbilityHuntleigh Healthcare · 2013
- Descendant · 2 generations on · 4 of its ownK200337 FloPatch (FP120)Flosonics Medical (R/A 1929803 Ontario Corp.) · 2020 · Recalled
- Descendant · 2 generations on · 4 of its ownK143152 TM-ABI systemLd Technology, LLC · 2015
- Descendant · 3 generations on · 3 of its ownK222242 FloPatch FP120Flosonics Medical · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K183574SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular ProbesHuntleigh Healthcare, Ltd. · 2019 · cites it directly5descendants
- K121108Dopplex AbilityHuntleigh Healthcare · 2013 · cites it directly5descendants
- K200337FloPatch (FP120)Flosonics Medical (R/A 1929803 Ontario Corp.) · 2020 · 2 generations on4descendants
- K143152TM-ABI systemLd Technology, LLC · 2015 · 2 generations on4descendants
- K222242FloPatch FP120Flosonics Medical · 2022 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002186 | Vascular Assist | Huntleigh Healthcare, Inc. | 2001 | — |
| +1 | K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes | Huntleigh Healthcare, Ltd. | 2019 | — |
| +1 | K121108 | Dopplex Ability | Huntleigh Healthcare | 2013 | — |
| +2 | K200337 | FloPatch (FP120) | Flosonics Medical (R/A 1929803 Ontario Corp.) | 2020 | 1 |
| +2 | K143152 | TM-ABI system | Ld Technology, LLC | 2015 | — |
| +3 | K222242 | FloPatch FP120 | Flosonics Medical | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DPW? 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 DPW device
- #1 K251114 FloPatch FP120score 13.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 6, 2005 | Not classified | Z-0865-05 | Other | The acoustic display of Mechanical Index and Thermal Index is inaccurate - two transducers may exceed limits for acoustic intensity and MI. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K183574 (Huntleigh Healthcare, Ltd., 2019) has gone furthest, with 5 descendants of its own.
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPW
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DPW
6in 2025
MAUDE reports naming product code DPW, 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 | — | 4 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 4 | 89 | 0 | 1 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 3 | 275 | 0 | 12 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 3 | 169 | 0 | 3 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 3 | 136 | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 119 | 1 | 6 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K002186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002186: Vascular Assist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002186
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026