Blood Pressure Monitor KP-7000
510(k) K032492
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032492 | Date9 Sep 2003 | 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- Withdrawn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
- Blood Pressure Monitor, Model Kp-7000
- 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 Blood Pressure Monitor KP-7000 is a non-invasive blood pressure measurement system designed to monitor systolic and diastolic blood pressure. Classified under 21 CFR 870.1130, it falls within the category of measurement systems for blood pressure and is intended for home or clinical use to provide continuous or periodic readings.
This device is supplied as a single-use or reusable unit, depending on manufacturer specifications, and is regulated under FDA 510(k) clearance (K032492) with a Substantially Equivalent (SESE) determination. It complies with applicable FDA-recognized consensus standards and is intended for use in environments where accurate blood pressure readings are required, such as patient monitoring or self-assessment. Storage and handling instructions are detailed in the manufacturer’s accompanying documentation.
Other devices from K-jump Health Co., Ltd.
Questions
AI-generated answers, 18 Sep 2026
Is the KP-7000 blood pressure monitor meant for use in hospitals or can it also be used at home?
The KP-7000 is designed for both home and clinical use, as it is classified under 21 CFR 870.1130 for blood pressure measurement systems. This versatility allows it to provide accurate readings in environments like patient monitoring settings or for self-assessment at home.
Can the KP-7000 be reused, or is it intended for single-use only?
The KP-7000 is supplied as either a single-use or reusable unit, depending on the manufacturer’s specifications. Since the data does not specify a default, you should refer to the manufacturer’s instructions for proper usage and disposal guidelines to ensure compliance with best practices.
What type of regulatory clearance does the KP-7000 blood pressure monitor have, and how does that affect its use?
The KP-7000 holds an FDA 510(k) clearance (K032492) with a Substantially Equivalent (SESE) determination, meaning it has been deemed comparable to a legally marketed device. This clearance allows it to be legally marketed and used in the U.S. for its intended purpose—measuring systolic and diastolic blood pressure in home or clinical settings.
How should I store the KP-7000 to maintain its accuracy and functionality?
The manufacturer’s accompanying documentation includes detailed storage and handling instructions for the KP-7000. Since these specifics are not provided in the data, you should consult the official user manual or contact K-jump Health Co., Ltd. for proper storage guidelines to ensure the device remains accurate and functional over time.
What types of environments is the KP-7000 intended for, and does it require any special conditions?
The KP-7000 is intended for use in environments where accurate blood pressure readings are critical, such as patient monitoring in clinical settings or self-assessment at home. While no special conditions are explicitly mentioned, adherence to the manufacturer’s storage and handling instructions—found in the accompanying documentation—will help ensure reliable performance.