CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System
by i-SENS, Inc.
510(k) K201394
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK201394 | Date5 Oct 2021 | 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- Withdrawn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
- NBW
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The CareSens N Feliz Blood Glucose Monitoring System is a Blood Glucose Monitoring Device (NBW product code) designed for self-monitoring of blood glucose levels. It provides rapid, accurate readings to support diabetes management, featuring auto-coding functionality to distinguish between pre-meal and post-meal measurements. The system includes a handheld meter with a large-capacity memory (up to 1,000 readings) and compatible test strips for convenient use.
This device is intended for single-use at home or portable settings, supplied as a kit including the meter, test strips, and accessories. It is not sterile and requires no regulatory sterilisation; compliance is confirmed via FDA 510(k) clearance under Special Review (K201394) as Substantially Equivalent to a predicate device, reviewed by the Clinical Chemistry (CH) Advisory Committee. No MRI safety or reusable components are specified.
Other devices from i-SENS, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the CareSens N Feliz Blood Glucose Monitoring System, and how does it help users manage diabetes?
The CareSens N Feliz Blood Glucose Monitoring System is designed for self-monitoring of blood glucose levels at home or in portable settings. It provides rapid and accurate readings to help users track their glucose levels, which is essential for effective diabetes management. The system includes auto-coding functionality to differentiate between pre-meal and post-meal measurements, making it easier to monitor trends and adjust care as needed.
Is the CareSens N Feliz Blood Glucose Monitoring System intended for single-use or reusable components, and how is it supplied?
The CareSens N Feliz Blood Glucose Monitoring System is intended for single-use of its test strips, while the handheld meter itself is reusable. It is supplied as a kit that includes the meter, test strips, and necessary accessories for convenient use at home or on the go.
How many blood glucose readings can the meter store, and what does the auto-coding feature do?
The handheld meter in the CareSens N Feliz system has a large-capacity memory that can store up to 1,000 readings. The auto-coding feature automatically distinguishes between pre-meal and post-meal measurements, helping users organize their data and track glucose trends more effectively.
Is the CareSens N Feliz Blood Glucose Monitoring System sterile, and what regulatory pathway was followed for its clearance?
No, the CareSens N Feliz Blood Glucose Monitoring System is not sterile. It was cleared by the FDA through a 510(k) submission (K201394) under Special Review, demonstrating substantial equivalence to a predicate device. The review was conducted by the Clinical Chemistry (CH) Advisory Committee, confirming compliance without requiring regulatory sterilization.
What type of settings is the CareSens N Feliz Blood Glucose Monitoring System intended for, and how does its design support portability?
The system is designed for use in home or portable settings, making it ideal for users who need to monitor glucose levels while traveling or away from a fixed location. The compact handheld meter and included accessories are packaged as a kit, ensuring convenience and ease of use in various environments.