# K022435: 507EL Vital Signs Monitor

- Pathway: 510(k) (Special)
- Applicant: Criticare Systems, Inc.
- Decided: Aug 14, 2002 after 20 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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 K944860 (1995). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944860: Scholar Patient Monitor, Criticare Systems, Inc. (1995) Summary page 1.

## Most influential descendants
- K051038: 506 Patient Monitor (2005), 4 descendants of its own
- K101259: V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002 (2010), 1 descendant of its own
- K091050: 506CN Patient Monitor (2009), 1 descendant of its own
- K172221: VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 (2018), 0 descendants of its own
- K101602: Vital Signs Monitor (2010), 0 descendants of its own

## Indications for use
This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.

Source page: https://510kreport.com/device/K022435
Methodology: https://510kreport.com/methodology