# K242487: Laminar P1 (LDH-HW-001)

- Pathway: 510(k) (Traditional)
- Applicant: Laminar Digital Health, Inc.
- Decided: Dec 13, 2024 after 114 days
- Product code: JAF (Monitor, Ultrasonic, Nonfetal)
- Device class: 2
- Regulation: 21 CFR 892.1540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K930200 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191388: FloPatch (FP110), Flosonics Medical (R/A 1929803 Ontario Corp.) (2019) Summary page 5.

## Indications for use
The Laminar P1 device is a wearable and disposable, ultrasound-based (4.5 MHz, continuous-wave) patch sensor designed to detect blood flow in peripheral vessels and assist in the detection of peripheral vascular disease. The Laminar P1 device is intended to be used by medical professionals, such as physicians and nurses, in hospitals, clinics and private offices and healthcare facilities. It is to be used on adults, ages 18 years and older.

Source page: https://510kreport.com/device/K242487
Methodology: https://510kreport.com/methodology