510(k) · Cleared
ClearedLaserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vasamedics, LLC · DPT Probe, Blood-Flow, Extravascular
Cleared on Mar 21, 1996 as substantially equivalent to K875179 (Tsi, Inc., 1988) and 1 other predicate after a 336-day review. Its family tree reaches back 1 generation to 1988. 26 later devices descend from it.
- Decided
- Mar 21, 1996
- Review
- 336 days
- Class
- Class II
- Product code
- DPT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K875179 (1988). 2 ancestors in all. 26 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK875179 Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc. · 1988
- This deviceK951832 Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434…Vasamedics, LLC · 1996
- Descendant · cites it directly · 24 of its ownK961368 Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC · 1996
- Descendant · 2 generations on · 22 of its ownK013930 NeurosensorNovus Monitoring, Ltd. · 2002
- Descendant · 3 generations on · 17 of its ownK050702 Neurosystems 1TM MonitorNeurosystems, LLC · 2005
- Descendant · 4 generations on · 15 of its ownK061640 Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006
- Descendant · 5 generations on · 14 of its ownK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K961368Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC · 1996 · cites it directly24descendants
- K013930NeurosensorNovus Monitoring, Ltd. · 2002 · 2 generations on22descendants
- K050702Neurosystems 1TM MonitorNeurosystems, LLC · 2005 · 3 generations on17descendants
- K061640Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006 · 4 generations on15descendants
- K080217Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · 5 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K875179 | Modified Laserflo Blood Perfusion Monitor, BPM403A | Tsi, Inc. | 1988 | — |
| 0 (this device) | K951832 | Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433 | Vasamedics, LLC | 1996 | — |
| +1 | K961368 | Trimflo Parenchymal Blood Flow Monitoring Probe Kit | Vasamedics, LLC | 1996 | — |
| +2 | K013930 | Neurosensor | Novus Monitoring, Ltd. | 2002 | — |
| +3 | K050702 | Neurosystems 1TM Monitor | Neurosystems, LLC | 2005 | — |
| +4 | K061640 | Integra Mobius Multi-Modality Monitoring System | Integra LifeSciences Corporation | 2006 | — |
| +5 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 DPT? 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 DPT device
- #1 K233076 Laser Speckle Imaging System (RFLSI CZW)score 8.6 · 5 generations · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K875179 | Modified Laserflo Blood Perfusion Monitor, BPM403ASummary page 1…e SUP- 440, SUPR-434 and the SUP- 433 are accessories to the Vasmedics’ BPM2 Blood perfusion Monitor, K896515 and equivalent to the Vasamedics’ Model P-433 Needle Probe, K875179, the Model PR-434 Implantable Prism Probe, K875179, and the P-440 Soflex Probe, K912446. Device Description: The Model BPMZ2 is… | 1988 |
| * | K912446 | Modif. Laserflo Blood Perfusion Monitor Model BPM2Summary page 1…sion Monitor, K896515 and equivalent to the Vasamedics’ Model P-433 Needle Probe, K875179, the Model PR-434 Implantable Prism Probe, K875179, and the P-440 Soflex Probe, K912446. Device Description: The Model BPMZ2 is a Laser Doppler Blood Perfusion Monitor, which is used to measure microgirculatory bloo… | 1991 |
What descends from it? (26)
See all 263 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K961368 (Vasamedics, LLC, 1996) has gone furthest, with 24 descendants of its own.
How does its category compare?
All DPT devicesDPT Probe, Blood-Flow, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPT
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DPT
201in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPT
22in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DPT
52in 2025
MAUDE reports naming product code DPT, 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 | 3 | 55 | 0 | 5 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 3 | 108 | 0 | 0 |
| 2014 | 3 | 201 | 0 | 5 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 0 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 21 |
| 2024 | 1 | — | 22 | 169 |
| 2025 | 0 | — | 0 | 52 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Single Use Probes are intended for extravascular monitoring of microcirculation blood flow in buried tissues. An example of this application is the monitoring of buried muscle or esophagus following free muscle transfer or esophageal reconstruction. Another example is monitoring soft tissue microcirculation following reconstructive surgerv, such as in oral and facial reconstruction. Yet another exampie is monitoring cerebral blood flow during and following neurosurgery for head trauma.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K951832 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951832: Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951832
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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