# K961368: Trimflo Parenchymal Blood Flow Monitoring Probe Kit

- Pathway: 510(k) (Traditional)
- Applicant: Vasamedics, LLC
- Decided: Oct 11, 1996 after 185 days
- Product code: DPT (Probe, Blood-Flow, Extravascular)
- Device class: 2
- Regulation: 21 CFR 870.2120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K875179 (1988). 3 ancestors in all.
24 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951832: Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433, Vasamedics, LLC (1996) Summary page 1.
- (no number) Codman disposable ICP system: named in the summary without a submission number

## Most influential descendants
- K013930: Neurosensor (2002), 22 descendants of its own
- K050702: Neurosystems 1TM Monitor (2005), 17 descendants of its own
- K061640: Integra Mobius Multi-Modality Monitoring System (2006), 15 descendants of its own
- K080217: Component Neuromonitoring System (2008), 14 descendants of its own
- K092573: Nihon Kohden QP-160AK Eeg Trend Program (2010), 7 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K961368
Methodology: https://510kreport.com/methodology