# K110438: Sensilase Pad-IQ

- Pathway: 510(k) (Abbreviated)
- Applicant: Vasamed, Inc.
- Decided: May 4, 2011 after 78 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- 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 K951486 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040654: Sensilase Pad 3000, Optical Sensors, Inc. (2004) Summary page 1.

## Indications for use
The SensiLase® PAD-IQ provides a noninvasive measurement of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR) waveforms on extremities of patients.

Source page: https://510kreport.com/device/K110438
Methodology: https://510kreport.com/methodology