Arm Blood Pressure Monitor, Models KP-6821, KP-6822
510(k) K043531
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK043531 | Date21 Apr 2005 | 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- Withdrawn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
- Modification to Arm Blood Pressure Monitor, Models Kp-6821, Kp-6822
- 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
This device is an arm-based blood pressure monitor designed to measure systolic, diastolic, and pulse rate in adult patients. It employs an inflatable cuff wrapped around the upper arm, a semiconductor sensor to detect pressure oscillations, and an internal air pump to control cuff inflation. Results are displayed on an integrated LCD screen for immediate patient review.
The monitor is operated manually via integrated keys and is intended for single-use or reusable applications in clinical or home settings, depending on manufacturer guidelines. It is classified under FDA regulation 870.1130 as a cardiovascular device and has received FDA 510(k) clearance under a special review process. No specific sterility or MRI safety information is provided in the available data.
Other devices from K-jump Health Co., Ltd.
Questions
AI-generated answers, 18 Sep 2026
What are the key differences between the KP-6821 and KP-6822 models of this blood pressure monitor?
The data provided does not specify any functional or design differences between the KP-6821 and KP-6822 models beyond their classification as a modification to the same arm-based blood pressure monitor. Both models share the same core features: an inflatable upper-arm cuff, a semiconductor sensor for pressure detection, an internal air pump, and an integrated LCD screen. The manufacturer’s guidelines would determine whether usage (single-use or reusable) varies by model, but no technical distinctions are outlined in the available information.
Can this device be reused in clinical settings, and if so, what are the manufacturer’s recommendations?
The device is designed for *either* single-use or reusable applications, depending on the manufacturer’s guidelines. Since no explicit instructions on reuse protocols, cleaning, or sterility requirements are provided in the data, clinicians should consult K-jump Health Co., Ltd.’s official documentation or contact their support team (e.g., via the listed contact, Daniel Tseng) for proper reuse procedures. Reuse would likely require adherence to infection control protocols if used in clinical environments.
How is this blood pressure monitor powered, and does it require any additional accessories?
The device operates manually via integrated keys and includes an internal air pump for cuff inflation, meaning it does not require external power sources or additional accessories beyond the cuff itself. The design implies a self-contained unit where the cuff, sensor, pump, and display are all integrated into one portable device, eliminating the need for external components like batteries or tubing.
What types of patients is this monitor intended to measure blood pressure for, and how accurate is the reading?
This monitor is specifically designed for measuring systolic, diastolic, and pulse rate in *adult patients* only. The accuracy of readings depends on proper cuff placement (wrapped around the upper arm), correct usage following manufacturer instructions, and adherence to standard blood pressure measurement protocols. No specific accuracy metrics (e.g., ±3 mmHg) are provided in the data, so clinicians should refer to the device’s user manual or validation studies for detailed performance details.
How should this device be stored, and are there any special handling instructions for the cuff?
The data does not specify storage conditions or cuff handling instructions, but standard practices for arm cuff blood pressure monitors typically recommend storing the device in a clean, dry place away from direct sunlight or extreme temperatures. If reusable, the cuff should be inspected for damage before use, and any manufacturer-recommended cleaning or maintenance steps should be followed. For single-use models, the cuff may be disposed of after one use, but this depends on the specific guidelines provided by K-jump Health Co., Ltd.