Drip Alert
by Drip Alert, Inc. 510(k)
Active
510(k) K030136
Overview
The Drip Alert is an Electric Monitor for Gravity Flow Infusion Systems, designed to detect and alert clinicians to changes in intravenous fluid administration rates. It functions as an automated monitoring device to ensure accurate fluid delivery, helping prevent complications such as infusion-related errors or disruptions in patient care. By continuously tracking the flow rate of intravenous fluids, it provides real-time feedback to healthcare providers, enhancing patient safety in clinical settings.
This device is intended for use in General Hospital environments and is supplied as a reusable medical instrument. It operates on electrical power and is classified under Device Class II regulatory standards, with an FDA 510(k) clearance (K030136) for traditional review. The Drip Alert is not sterile and must be cleaned and maintained according to manufacturer guidelines. It is designed for single-patient use per session, though its reusable components require proper disinfection between uses. No MRI safety information is specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK030136 | Date7 Apr 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
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
Questions
What is the Drip Alert used for?
The Drip Alert is an electric monitor designed specifically for gravity flow infusion systems. It continuously tracks intravenous fluid administration rates and alerts clinicians to any changes or disruptions, helping prevent infusion-related errors and improving patient safety during fluid therapy in hospital settings.
Is the Drip Alert a single-use or reusable device?
The Drip Alert is classified as a reusable medical instrument. While it is intended for single-patient use per session, its components must undergo proper disinfection between uses to maintain safety and functionality. Follow the manufacturer’s cleaning and maintenance guidelines to ensure reliable performance.
Does the Drip Alert come pre-sterilized?
No, the Drip Alert is not sterile out of the box. It must be cleaned and maintained according to the manufacturer’s instructions before and after each use to ensure proper hygiene and functionality. Sterility is not a feature of this device.
What type of power does the Drip Alert require?
The Drip Alert operates using electrical power. No specific voltage or power source details are provided beyond its classification as an electric monitor, so ensure compatibility with the facility’s standard medical-grade power supply.
How is the Drip Alert regulated?
The Drip Alert holds FDA 510(k) clearance (K030136) under traditional review, classified as a Device Class II product. It is intended for use in general hospital environments and adheres to regulatory standards for monitoring infusion systems.