# K033025: Tytan Professional /Economy Series Sphygmomanometer, NO 710/NO 700

- Pathway: 510(k) (Traditional)
- Applicant: Tytan Medical Corp.
- Decided: Dec 10, 2003 after 75 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K092893: Tytan Automatic Aneroid Sphygmomanometer, Model A730 and Manual Digital LCD Sphygmomanometer, Model A830 Series (2010), 0 descendants of its own

## Indications for use
The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference ranges are 3 1/2" to 5 1/4", 3 3/4" to 7 1/2", 7" to 10 3/4", 10 3/4" to 15 3/4", and 13 1/3" to 19 1/2". The patient population targets are newborn, infant, child, adult.

Source page: https://510kreport.com/device/K033025
Methodology: https://510kreport.com/methodology