# K022618: X-Scribe II

- Pathway: 510(k) (Special)
- Applicant: Mortara Instrument, Inc.
- Decided: Sep 6, 2002 after 30 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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 K900720 (1990). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900720: Mortara Instrument Model X-Scribe (Treadmill Included), Mortara Instrument, Inc. (1990) Summary page 1.
- K001492: Quinton Q-Stress, Model 000483, Quinton, Inc. (2000) Summary page 1.

## Most influential descendants
- K152944: Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems (2016), 0 descendants of its own
- K092663: Eli 350 Electrocardiograph (2009), 0 descendants of its own

## Indications for use
The device is indicated for use to acquire, process, record, archive, analyze, and output electrocardiographic data obtained during physiologic stress exercise testing. The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. The device is indicated for use on adult populations, typically symptomatic. The device is not intended to be used as a vital signs physiological monitor.

Source page: https://510kreport.com/device/K022618
Methodology: https://510kreport.com/methodology