FDA product code FIZ: Meter, Conductivity, Non-Remote
FIZ is the FDA product code for meter, conductivity, non-remote. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 13 510(k) submissions under FIZ, from 7 different applicants. The average 510(k) review took 94 days (median 65).
Classification
| Field | Value |
|---|---|
| Device name | Meter, Conductivity, Non-Remote |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for FIZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 65 |
Compare with all 510(k) review times · Search every FIZ clearance
Top FIZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mesa Laboratories, Inc. | 3 | 2020-09-02 |
| Ibp Instruments GmbH | 2 | 2002-05-22 |
| Automata Instrumentation, Inc. | 2 | 1999-10-13 |
| Automata Medical Instrumentation, Inc. | 2 | 1996-02-29 |
| Automata, Inc. | 2 | 1988-04-21 |
2 more applicants have FIZ clearances. See the full list in Caduvo.
Most recent FIZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201765 | Mesa Laboratories, Inc. | SmartHDM-510 System | 2020-09-02 | 65 |
| K150657 | Mesa Laboratories, Inc. | Phoenix XL Dialysate Meter | 2015-09-21 | 192 |
| K050812 | Mesa Laboratories, Inc. | 90XL INSTRUMENTATION SYSTEM | 2005-05-05 | 35 |
| K020908 | Ibp Instruments GmbH | HDM97 | 2002-05-22 | 63 |
| K020909 | Ibp Instruments GmbH | HDM99 | 2002-05-22 | 63 |
Recalls for FIZ devices
openFDA lists no recalls for product code FIZ.
Frequently asked questions
What is FDA product code FIZ?
FIZ is the FDA product code for meter, conductivity, non-remote. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FIZ?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FIZ?
Across 13 cleared submissions the average was 94 days from receipt to decision (median 65).
Which companies have the most FIZ clearances?
Mesa Laboratories, Inc. (3); Ibp Instruments GmbH (2); Automata Instrumentation, Inc. (2); Automata Medical Instrumentation, Inc. (2); Automata, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code FIZ
- Run a recall and safety report across every FIZ manufacturer
- Watch product code FIZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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