510(k) · Decided
DecidedTrimflo Parenchymal Blood Flow Monitoring Probe Kit
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 Oct 11, 1996 as substantially equivalent to K951832 (Vasamedics, LLC, 1996) after a 185-day review. Its family tree reaches back 2 generations to 1988. 24 later devices descend from it.
- Decided
- Oct 11, 1996
- Review
- 185 days
- Class
- Class II
- Product code
- DPT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K875179 (1988). 3 ancestors in all. 24 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK875179 Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc. · 1988
- 1 generation backK951832 Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434…Vasamedics, LLC · 1996
- This deviceK961368 Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC · 1996
- Descendant · cites it directly · 22 of its ownK013930 NeurosensorNovus Monitoring, Ltd. · 2002
- Descendant · 2 generations on · 17 of its ownK050702 Neurosystems 1TM MonitorNeurosystems, LLC · 2005
- Descendant · 3 generations on · 15 of its ownK061640 Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006
- Descendant · 4 generations on · 14 of its ownK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- Descendant · 5 generations on · 7 of its ownK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K013930NeurosensorNovus Monitoring, Ltd. · 2002 · cites it directly22descendants
- K050702Neurosystems 1TM MonitorNeurosystems, LLC · 2005 · 2 generations on17descendants
- K061640Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006 · 3 generations on15descendants
- K080217Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · 4 generations on14descendants
- K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K875179 | Modified Laserflo Blood Perfusion Monitor, BPM403A | Tsi, Inc. | 1988 | — |
| −1 | K951832 | Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433 | Vasamedics, LLC | 1996 | — |
| 0 (this device) | K961368 | Trimflo Parenchymal Blood Flow Monitoring Probe Kit | Vasamedics, LLC | 1996 | — |
| +1 | K013930 | Neurosensor | Novus Monitoring, Ltd. | 2002 | — |
| +2 | K050702 | Neurosystems 1TM Monitor | Neurosystems, LLC | 2005 | — |
| +3 | K061640 | Integra Mobius Multi-Modality Monitoring System | Integra LifeSciences Corporation | 2006 | — |
| +4 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| +5 | K092573 | Nihon Kohden QP-160AK Eeg Trend Program | Nihon Kohden America, Inc. | 2010 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K951832 | Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433Summary page 1…k) Summary OCT 11 1096 Device Name: Trimflo Parenchymal Blood Flow Monitoring Probe Kit Predicate Device: The Vasamedics’ model SUPR-434 Single use Blunt Needle Probe, K951832 and for kit accessories the Codman disposable ICP system (believed to be a pre-amendment device). Device Description: The Model… | 1996 |
| * | — | Codman disposable ICP system Named without a submission number |
What descends from it? (24)
See all 242 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 7.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K013930 (Novus Monitoring, Ltd., 2002) has gone furthest, with 22 descendants of its own.
- 2 other devices also cite its predicate K951832.
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 probes kits are intended for extravascular monitoring of microcirculation blood flow in buried tissues, specifically, in monitoring cerebral blood flow in patients at risk of cerebral ischemia.
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/K961368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961368: Trimflo Parenchymal Blood Flow Monitoring Probe Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961368
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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