Ortiv (Ortiv-Bl, Ortiv-Wh)
510(k) K241646
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241646 | Date1 Nov 2024 | 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- Withdrawn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
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
ORTIV is a personal blood glucose monitoring device designed for diabetic patients. It integrates a laser-based blood collection system with a glucose meter, enabling painless blood sampling and immediate glucose measurement in a single handheld unit. The device features eight adjustable laser levels to optimize blood collection efficiency and accuracy. Its design eliminates the need for traditional finger-prick lancets, reducing discomfort and waste from disposable needles.
ORTIV is supplied as a reusable, non-sterile handheld device intended for home use. It operates without MRI compatibility restrictions and is available in two variants: ORTIV-BL and ORTIV-WH. The device holds FDA 510(k) clearance under the General, Plastic Surgery advisory committee classification (K241646). Storage instructions and sterility requirements are not specified in the regulatory data, but standard hygiene practices should be followed to maintain device integrity.
Questions
AI-generated answers, 1 Oct 2026
What is the ORTIV device used for?
ORTIV is designed for diabetic patients to monitor blood glucose levels at home. It replaces traditional finger-prick lancets with a laser-based blood collection system, allowing for painless sampling and immediate glucose measurement in a single handheld device. This integration simplifies the monitoring process while reducing discomfort and waste from disposable needles.
How is the ORTIV device supplied and intended for use?
ORTIV is supplied as a reusable, non-sterile handheld device intended exclusively for home use. It is not sterile and requires adherence to standard hygiene practices to maintain its functionality and safety. The device is not compatible with MRI environments and is available in two variants: ORTIV-BL and ORTIV-WH.
Does ORTIV require single-use or can it be reused?
ORTIV is explicitly designed as a reusable device, meaning it is intended for long-term use by individual patients. Unlike single-use devices, it does not require disposal after each use, which helps reduce waste. However, proper cleaning and maintenance are essential to ensure its continued accuracy and safety.
What distinguishes the ORTIV-BL and ORTIV-WH models?
The ORTIV device comes in two variants, ORTIV-BL and ORTIV-WH, though the regulatory data does not specify exact differences between them beyond the model designation. The distinction may relate to minor design or feature variations, such as color, aesthetic preferences, or compatibility with specific user needs. Both models share the same core functionality of laser-based blood collection and glucose measurement.
Are there any special storage requirements for the ORTIV device?
The regulatory data does not provide explicit storage instructions for ORTIV, but standard hygiene practices should be followed to preserve the device’s integrity. Since it is reusable and non-sterile, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Users should also avoid exposing the device to moisture or contaminants to maintain its performance and longevity.