Lifeclinic Model 2400
by Lifeclinic International, Inc.
510(k) K040562
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040562 | Date31 Aug 2004 | 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- Withdrawn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
- 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, 1 Oct 2026
The Lifeclinic Model 2400 is an automated, non‑invasive blood pressure and pulse‑rate monitor that measures blood pressure by the oscillometric method. It provides automated readings of systolic and diastolic pressure as well as pulse rate for the general public.
The device is intended for use in retail, public, or clinical settings where a user inserts an arm into a fixed cuff and initiates measurement with a button press, guided by interactive screens and voice instructions. It is classified as a Class II device with a special FDA 510(k) clearance (K040562, product code DXN) and is supplied as a reusable, non‑sterile system.
Questions
AI-generated answers, 1 Oct 2026
What type of measurement method does the Model 2400 use?
It measures blood pressure using the oscillometric method, which detects pressure fluctuations in the cuff to calculate systolic and diastolic values, providing reliable readings without the need for a stethoscope.
Is the device intended for single‑use or reusable applications?
The Model 2400 is supplied as a reusable, non‑sterile system. The cuff and arm interface can be cleaned between patients, making it appropriate for settings with multiple users such as retail kiosks or clinics.
What environments are appropriate for installing the Model 2400?
It is designed for retail, public, or clinical settings where users can place an arm into a fixed cuff and start a measurement with a button. Interactive screens and voice prompts guide the process, so it works well in high‑traffic areas like pharmacies, community health centers, or hospital waiting rooms.
How is the Model 2400 regulated and what clearance does it have?
The device is classified as a Class II medical device and received a special FDA 510(k) clearance (K040562) with product code DXN, indicating it is substantially equivalent to a legally marketed predicate device.