# K180335: Accutension Smartphone Auscultatory Blood

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Hulu Devices Co., Ltd.
- Decided: Mar 8, 2018 after 30 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: 4 generations back to K790810 (1979). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043286: Aneroid Sphygmomanometer, Model BK2002, Wenzhou Bokang Instrument Co.,Ltd (2005) Summary page 4.
- K133383: HEM-7320, Omron Healthcare, Inc. (2014) Summary page 4.

## Indications for use
Accutension Smartphone Auscultatory Blood Pressure Kit is intended for professionals or home users to nonautomatically measure systolic and diastolic blood pressure on adults by detecting Korotkoff sounds and measure pulse rate on adults by detecting oscillometry. This device is not indicated for children, heart failure patients and critical patients.

Source page: https://510kreport.com/device/K180335
Methodology: https://510kreport.com/methodology