Auto Digital Upper Arm Blood Pressure Monitor KP-7770
510(k) K092806
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK092806 | Date9 Oct 2009 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Auto Digital Upper Arm Blood Pressure Monitor, Model Kp-7770
- 510(k) Number
- FDA Product Code
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Auto Digital Upper Arm Blood Pressure Monitor KP-7770 is a non-invasive, automatic device designed for measuring systolic and diastolic blood pressure, as well as pulse rate in adult patients. It employs an inflating cuff, bellows sensor, internal air pump, and leakage/exhaust valves to detect and process pressure signals via MOMI or fuzzy logic algorithms, then displays results on an LCD screen. The device is intended for use by patients or clinicians in clinical or home settings.
This device is supplied as a reusable electronic monitor and requires no sterilisation. It is classified under FDA product code DXN and has received a Special 510(k) clearance under the Cardiovascular advisory committee. The KP-7770 is intended for single-user operation and should be stored in a clean, dry environment to maintain functionality. No specific MRI safety information is provided in the submitted data.
Other devices from K-jump Health Co., Ltd.
Questions
AI-generated answers, 18 Sep 2026
Is this blood pressure monitor intended for use by patients at home or only in clinical settings?
The KP-7770 is designed for use in both clinical and home settings, allowing patients or clinicians to measure systolic and diastolic blood pressure, as well as pulse rate. Its automatic operation and LCD display make it accessible for self-use by patients.
How is the KP-7770 different from other blood pressure monitors in terms of measurement technology?
The KP-7770 uses an inflating cuff, bellows sensor, internal air pump, and leakage/exhaust valves to detect pressure signals. It processes these signals via MOMI or fuzzy logic algorithms, which help improve accuracy and reliability compared to simpler oscillometric monitors.
Does this device require sterilization, and how should it be maintained?
The KP-7770 is a reusable electronic monitor and does not require sterilization. To maintain functionality, it should be stored in a clean, dry environment and intended for single-user operation only, reducing the risk of contamination.
What regulatory pathway was followed for FDA clearance of this device?
The KP-7770 received a Special 510(k) clearance under the Cardiovascular advisory committee, meaning it was determined to be substantially equivalent to a legally marketed predicate device. The clearance was granted on October 9, 2009.
Can this monitor be used on patients of all ages, or is it specifically for adults?
The KP-7770 is explicitly designed for measuring blood pressure in adult patients only, as indicated in its description. It is not intended for pediatric or infant use.