# K143332: Fast Sphyg by Koven

- Pathway: 510(k) (Traditional)
- Applicant: Koven Technology, Inc.
- Decided: Apr 14, 2015 after 145 days
- Product code: DXQ (Blood Pressure Cuff)
- Device class: 2
- Regulation: 21 CFR 870.1120
- 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 K962655 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962655: Aneroid and Mercurial Sphygmomanometers, American Diagnostic Corp. (1997) Summary page 4.

## Indications for use
The device is a sphygmomanometer intended to be used with a stethoscope or Doppler for indirect measurement of arterial blood pressure. This device includes an aneroid gauge. Koven Technology, Inc. intends to provide the device for use by healthcare providers. Our product is for both hospital and clinical use and are intended for pediatric through adults, excluding neonates.

Source page: https://510kreport.com/device/K143332
Methodology: https://510kreport.com/methodology