Intra-Alert
510(k) K781297
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781297 | Date25 Oct 1978 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 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- Withdrawn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 Intra-Alert is an Electric Monitor for Gravity Flow Infusion Systems, designed to alert clinicians to the status of intravenous (IV) fluid administration. It operates within infusion setups to provide visual or audible signals when fluid flow deviates from expected parameters, ensuring patient safety by preventing complications such as over- or under-infusion.
This device is intended for use in general hospital settings and is supplied as a reusable medical monitor. It is classified under FDA device class 2 and holds a 510(k) clearance (K781297) for traditional review. The Intra-Alert adheres to regulatory standards for infusion monitoring, with no explicit MRI safety or sterility requirements noted in its specifications. Storage and maintenance instructions are not detailed in the available data.
Other devices from Pan-Tech Research, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Intra-Alert used for?
The Intra-Alert is an electric monitor designed specifically for gravity flow infusion systems in hospitals. It provides visual or audible alerts when intravenous (IV) fluid administration deviates from expected parameters, helping clinicians avoid complications like over- or under-infusion. This ensures patient safety during IV therapy by continuously monitoring flow rates.
Is the Intra-Alert reusable or single-use?
The Intra-Alert is supplied as a reusable medical monitor. Unlike disposable devices, it is intended for repeated use in clinical settings, provided it is properly maintained and cleaned according to manufacturer guidelines. This design supports cost efficiency in hospital environments where multiple patients require IV monitoring.
Does the Intra-Alert require sterilization before use?
The available specifications for the Intra-Alert do not mention explicit sterility requirements. Since it is a reusable device, it should be cleaned and maintained per the manufacturer’s instructions to ensure hygiene and functionality. Sterilization protocols would depend on the device’s materials and intended reuse cycles, but no direct sterility claims are noted in the documentation.
What types of infusion systems is the Intra-Alert compatible with?
The Intra-Alert is designed exclusively for gravity flow infusion systems, which rely on the natural force of gravity to deliver IV fluids. It is not intended for use with electronic infusion pumps or other pressurized delivery methods. The device’s purpose is to monitor and alert clinicians about deviations in flow rates within these gravity-dependent setups.
How is the Intra-Alert regulated and approved?
The Intra-Alert holds FDA 510(k) clearance (K781297) under traditional review, classified as a Class 2 medical device. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device and meets regulatory standards for infusion monitoring in general hospital settings. No additional regulatory details (e.g., MRI safety or sterility) are specified in the available data.