# K013434: VP-2000/1000

- Pathway: 510(k) (Traditional)
- Applicant: Colin Corp.
- Decided: Jul 9, 2002 after 266 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- 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 K872291 (1987). 8 ancestors in all.
46 later devices descend from it; 7 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921048: BP8800T/8000IR/8300G Non-Invasive Blood Pres. Syst, Colin Medical Instruments Corp. (1993) Summary page 1.
- K973637: Press-Mate Advantage, Colin Medical Instruments Corp. (1998) Summary page 1.
- K973562: Imex Medical Systems, Inc. Imexlab 9100, Imex Medical Systems, Inc. (1998) Summary page 1.
- K922668: Pilot Model 9200 Blood Pressure Measurement System, Colin Medical Instruments Corp. (1997) Summary page 1.
- K990809: Cadiscope Electronic Stethoscope, Caditec AG (1999) Summary page 1.

## Most influential descendants
- K082357: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office (TWIN200). (2008), 27 descendants of its own
- K151869: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2015), 15 descendants of its own
- K153077: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2016), 12 descendants of its own
- K080670: Modification to Sphygmocor Cardiovascular Management System (2008), 8 descendants of its own
- K122129: Sphygmocor Xcel (2012), 6 descendants of its own

## Indications for use
VP-2000/1000 is a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases. It has a capability of measuring; non-invasive blood pressures, heart rate, pulse wave, and heart sound It also has a capability of calculating AB1 (Ankle Brachial Index), Pulse Wave Velocity, and Augmentation Index. The instrument is used in a vascular laboratory, clinic, hospital, doctor’s office, and other medical facilities where the non-invasive peripheral vascular test is conducted. It is used on adult patients only.

Source page: https://510kreport.com/device/K013434
Methodology: https://510kreport.com/methodology