510(k) · Cleared
ClearedVentricular Catheter Blood Flow Monitoring Probe Kit and Ventraflo 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 Apr 9, 1997 as substantially equivalent to K951832 (Vasamedics, LLC, 1996) after a 271-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Apr 9, 1997
- Review
- 271 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. 1 later device descends from it, 1 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 deviceK962700 Ventricular Catheter Blood Flow Monitoring Probe Kit and Ventraflo…Vasamedics, LLC · 1997
- Descendant · cites it directly · 0 of its ownK013376 Qflow 500 Perfusion Monitoring SystemHemedex Incorporated · 2002
Most influential descendants
Showing 1 of 1 · See all- K013376Qflow 500 Perfusion Monitoring SystemHemedex Incorporated · 2002 · cites it directly0descendants
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) | K962700 | Ventricular Catheter Blood Flow Monitoring Probe Kit and Ventraflo Blood Flow… | Vasamedics, LLC | 1997 | — |
| +1 | K013376 | Qflow 500 Perfusion Monitoring System | Hemedex Incorporated | 2002 | — |
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 | 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? (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 |
|---|---|---|---|
| * | K951832 | Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433Summary page 1…ally equivalent to products currently in commercial distribution. Specifically, for the laser Doppler Probe the Vasamedics® model SUPR-434 Single use Blunt Needle Probe, K951832, for kit accessories and ventricular catheter the PS Medical “Becker Ventricular Catheter” and the “PS Medical Ventriculostomy Ki… | 1996 |
| * | — | PS Medical “Becker Ventricular Catheter” Named without a submission number | |
| * | — | PS Medical “Ventriculostomy Kit” Named without a submission number | |
| † | K896515 | Laserflo Blood Perfusion Monitor, Model BPM2 | 1990 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013376 | Qflow 500 Perfusion Monitoring System | 2002 | 0 |
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 9 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, K013376 (Hemedex Incorporated, 2002) has gone furthest, with 0 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/K962700 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962700: Ventricular Catheter Blood Flow Monitoring Probe Kit and Ventraflo 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/K962700
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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