# K040654: Sensilase Pad 3000

- Pathway: 510(k) (Abbreviated)
- Applicant: Optical Sensors, Inc.
- Decided: Jun 4, 2004 after 84 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: 1 generation back to K951486 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951486: Model PV2000 Vascular Microlaboratory, Vasamedics, LLC (1995) Summary page 1.

## Most influential descendants
- K110438: Sensilase Pad-IQ (2011), 0 descendants of its own

## Indications for use
The SensiLase TM PAD 3000 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/K040654
Methodology: https://510kreport.com/methodology