# K201720: LiPPS Analyzer, LiPPS Wire Pressure Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Bywave Sensing Medical Technology Co., Ltd.
- Decided: Feb 18, 2021 after 240 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- 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 K823434 (1982). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142598: Opto Wire and OptoMonitor System, Opsens, Inc. (2015) Summary page 4.
- K111395: Primewire Prestige Plus, Volcano Corporation (2011) Summary page 4.

## Indications for use
LiPPSTM Intravascular Pressure Sensing System is intended to be used in an environment like cathlab and for use in blood vessels, including coronary and peripheral vessels, to measure intravascular pressure during angiography and/or interventional procedures. Pressure measurements are obtained to provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel diseases.

Source page: https://510kreport.com/device/K201720
Methodology: https://510kreport.com/methodology