# K021219: Smartwire/Smartmap Pressure System

- Pathway: 510(k) (Special)
- Applicant: Jomed, Inc.
- Decided: May 17, 2002 after 30 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: 2 generations back to K823434 (1982). 12 ancestors in all.
90 later devices descend from it; 6 cite it directly.
7 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965140: Cardiometrics Wavewire/Wavemap Pressure System, Cardio Metrics, Inc. (1997) Summary page 1.

## Most influential descendants
- K041134: Combomap Pressure and Flow System (2004), 85 descendants of its own
- K070487: Smartwire Pressure Guide Wire, Model 66XX (2007), 44 descendants of its own
- K081625: Flowpicc Stylet (2008), 40 descendants of its own
- K081626: Flowpicc Console (2008), 39 descendants of its own
- K091324: Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet (2009), 38 descendants of its own

## Indications for use
The SmartWire/SmartMap Pressure System is indicated for use in all blood vessels, including coronary and peripheral arteries to measures blood pressure during diagnostic angiography and/or interventional procedures.

Source page: https://510kreport.com/device/K021219
Methodology: https://510kreport.com/methodology