# K993341: Intellisystem II Color Monitor

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Oct 25, 1999 after 20 days
- Product code: MAV (Syringe, Balloon Inflation)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K884913 (1989). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884913: Merit Intelliflator (TM) & Merit Monitor (TM), Merit Medical Systems, Inc. (1989) Summary page 1.

## Most influential descendants
- K140943: Mastro Plus Balloon in-Deflation Device (2015), 0 descendants of its own
- K050753: Stryker Discmonitor (2005), 0 descendants of its own

## Recalls of this device
- Nov 7, 2005 · Not classified · Z-0351-06: Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard.
- Nov 7, 2005 · Not classified · Z-0348-06: Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard.
- Nov 7, 2005 · Not classified · Z-0349-06: Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard.
- Nov 7, 2005 · Not classified · Z-0350-06: Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard.

## Indications for use
The Merit Medical INTELLISYSTEM II MONITOR is for use only with the disposable INITELLISYSTEMZ2S5 Syringe. It may be used to monitor the pressure of interventional devices as well as measure injectate pressures in various areas of the body.

Source page: https://510kreport.com/device/K993341
Methodology: https://510kreport.com/methodology