# K012194: Blood Pressure Monitor (Sphygmomanometer), Model HT-110

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Seimitsu Sokki Co., Ltd.
- Decided: Jul 20, 2001 after 7 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: 2 generations back to K790810 (1979). 6 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974080: Critikon Soft Blood Pressure Cuff, Johnson & Johnson Medical, Inc. (1998) Summary page 1.
- K940214: Statcorp Inc. Disposable Blood Pressure Cuff, Statcorp, Inc. (1994) Summary page 1.

## Most influential descendants
- K043286: Aneroid Sphygmomanometer, Model BK2002 (2005), 13 descendants of its own
- K173246: Aneroid Sphygmomanometer (2018), 10 descendants of its own
- K190902: RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope (2019), 9 descendants of its own
- K192500: Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer (2020), 3 descendants of its own
- K211084: Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope (2021), 2 descendants of its own

## Indications for use
Device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds

Source page: https://510kreport.com/device/K012194
Methodology: https://510kreport.com/methodology