I.V. Drip Monitor Alarm Device Moniflo
510(k) K760931
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK760931 | Date5 Jan 1977 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FLN
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2420
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The I.V. Drip Monitor Alarm Device, Moniflo, is an Electric Monitor for Gravity Flow Infusion Systems, designed to electronically monitor and alert for deviations in intravenous fluid administration. It incorporates a transducer and signal-processing components to detect and display infusion rates, ensuring precise fluid delivery in clinical settings. This device is classified under the FDA’s product code FLN and is intended for use in general hospital environments.
The Moniflo is supplied as a reusable medical device and is regulated under FDA’s 510(k) clearance (K760931) with a traditional review pathway, classified as a Class II device. It operates in hospital settings where gravity-based IV infusion systems are standard, requiring no additional sterility beyond standard medical device cleaning protocols. The device’s regulatory submission was filed under the General Hospital specialty category and is authorized for use in accordance with FDA’s 21 CFR 880.2420. No MRI safety or single-use specifications are noted in the regulatory data.
Other devices from Diemolding Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Moniflo I.V. Drip Monitor Alarm Device used for?
The Moniflo I.V. Drip Monitor Alarm Device is designed to electronically monitor and alert clinicians about deviations in intravenous fluid administration rates within gravity flow infusion systems. It uses a transducer and signal-processing components to detect and display infusion rates, helping maintain precise fluid delivery in clinical environments where gravity-based IV systems are standard.
Is the Moniflo device single-use or reusable?
The Moniflo I.V. Drip Monitor Alarm Device is a reusable medical device. It is intended for repeated use in hospital settings, provided it undergoes standard medical device cleaning protocols between uses. No additional sterility measures beyond routine cleaning are specified in the regulatory data.
What regulatory pathway does the Moniflo follow?
The Moniflo device is classified as a Class II medical device and was cleared through the FDA’s 510(k) pathway with a traditional review. The submission was filed under the General Hospital specialty category and authorized under 21 CFR 880.2420. The clearance number is K760931, and it was determined to be substantially equivalent to a predicate device.
Does the Moniflo device require special storage conditions?
The regulatory data does not specify any special storage conditions beyond standard practices for reusable medical devices. Since it is intended for use in hospital environments, it should be stored in a clean, dry area away from direct sunlight or extreme temperatures to preserve its functionality and ensure proper cleaning between uses.
What types of hospitals or settings is the Moniflo device intended for?
The Moniflo I.V. Drip Monitor Alarm Device is specifically intended for use in general hospital environments where gravity-based IV infusion systems are standard. It is not noted for use in specialized settings like MRI-compatible environments or pediatric-only facilities, though its application may extend to any clinical area requiring precise IV fluid monitoring.