510(k) · Cleared
ClearedModel PV2000 Vascular Microlaboratory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vasamedics, LLC · DPW Flowmeter, Blood, Cardiovascular
Cleared on Jun 29, 1995 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jun 29, 1995
- Review
- 91 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK951486 Model PV2000 Vascular MicrolaboratoryVasamedics, LLC · 1995
- Descendant · cites it directly · 3 of its ownK011899 PF 5050 Pressure Unit, Model PF 5050Perimed AB · 2001
- Descendant · 2 generations on · 1 of its ownK152930 PeriFlux6000Perimed AB · 2016
- Descendant · cites it directly · 1 of its ownK040654 Sensilase Pad 3000Optical Sensors, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK243852 Elfor-LElfi-Tech, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK110438 Sensilase Pad-IQVasamed, Inc. · 2011
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K011899PF 5050 Pressure Unit, Model PF 5050Perimed AB · 2001 · cites it directly3descendants
- K152930PeriFlux6000Perimed AB · 2016 · 2 generations on1descendant
- K040654Sensilase Pad 3000Optical Sensors, Inc. · 2004 · cites it directly1descendant
- K243852Elfor-LElfi-Tech, Ltd. · 2025 · 3 generations on0descendants
- K110438Sensilase Pad-IQVasamed, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951486 | Model PV2000 Vascular Microlaboratory | Vasamedics, LLC | 1995 | — |
| +1 | K011899 | PF 5050 Pressure Unit, Model PF 5050 | Perimed AB | 2001 | — |
| +2 | K152930 | PeriFlux6000 | Perimed AB | 2016 | — |
| +1 | K040654 | Sensilase Pad 3000 | Optical Sensors, Inc. | 2004 | — |
| +3 | K243852 | Elfor-L | Elfi-Tech, Ltd. | 2025 | — |
| +2 | K110438 | Sensilase Pad-IQ | Vasamed, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 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? (6)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K011899 (Perimed AB, 2001) has gone furthest, with 3 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/K951486 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951486: Model PV2000 Vascular Microlaboratory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951486
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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