HDM99
510(k) K020909
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK020909 | Date22 May 2002 | 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- Withdrawn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
- FIZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The HDM99 is a Conductivity Meter, Non-Remote (per FDA classification FIZ) designed to measure electrical conductivity in dialysis solutions. It falls under the Device Type classification of non-remote conductivity meters, intended for laboratory and clinical use in assessing fluid conductivity during dialysis procedures. The device operates as a standalone instrument, providing precise readings essential for ensuring treatment efficacy and patient safety in hemodialysis applications.
The HDM99 is supplied as a reusable medical device, intended for use in Gastroenterology and Urology settings as per FDA advisory committee records. It requires proper calibration and maintenance per manufacturer guidelines, with no specified sterility requirements beyond standard laboratory hygiene. The device is FDA-cleared under 510(k) K020909 (Traditional pathway) and classified as Class II, adhering to regulatory standards for non-invasive diagnostic meters. Storage conditions are not detailed in regulatory filings but should follow general electrical equipment protocols.
Other devices from Ibp Instruments GmbH
Questions
AI-generated answers, 1 Oct 2026
What is the HDM99 Conductivity Meter used for?
The HDM99 is designed to measure electrical conductivity in dialysis solutions, which is critical for assessing fluid conductivity during hemodialysis procedures. Accurate readings help ensure treatment efficacy and patient safety by confirming the proper functioning of dialysis fluids.
Is the HDM99 a single-use or reusable device?
The HDM99 is a reusable medical device. While it does not require specific sterility beyond standard laboratory hygiene, it must be properly calibrated and maintained according to the manufacturer’s guidelines to ensure reliable performance over repeated use.
In which clinical settings is the HDM99 intended for use?
The HDM99 is FDA-advisory classified for use in Gastroenterology and Urology settings, though its primary application is in hemodialysis procedures. Its role in these broader specialties may relate to fluid analysis or related diagnostic assessments, though its core function remains conductivity measurement for dialysis solutions.
Does the HDM99 require special storage conditions?
Regulatory filings do not specify unique storage requirements for the HDM99 beyond standard protocols for electrical medical equipment. It should be stored in a clean, dry environment, protected from physical damage and extreme temperatures to maintain calibration and functionality.
What regulatory pathway was followed for FDA clearance of the HDM99?
The HDM99 was cleared via the Traditional 510(k) pathway under K020909, determined to be Substantially Equivalent to a predicate device. It is classified as a Class II device under FDA regulations, adhering to standards for non-invasive diagnostic meters like conductivity analyzers.