FDA product code FKH: Solution-Test Standard-Conductivity, Dialysis
FKH is the FDA product code for solution-test standard-conductivity, dialysis. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 8 510(k) submissions under FKH, from 6 different applicants. The average 510(k) review took 60 days (median 65). FDA has posted 2 recalls for FKH devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Solution-Test Standard-Conductivity, Dialysis |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FKH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 61 |
Compare with all 510(k) review times · Search every FKH clearance
Top FKH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mesa Laboratories, Inc. | 3 | 2019-08-05 |
| H & S Technical Services | 1 | 2004-07-02 |
| Ibp Instruments GmbH | 1 | 2003-09-17 |
| D.R.G. Scientific Industries | 1 | 1986-10-24 |
| Rna Medical Corp. | 1 | 1985-06-12 |
1 more applicants have FKH clearances. See the full list in Caduvo.
Most recent FKH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191496 | Mesa Laboratories, Inc. | TDS Standard Solution | 2019-08-05 | 61 |
| K130100 | Mesa Laboratories, Inc. | COMINED STANDARD SOLUTION | 2013-04-18 | 93 |
| K041636 | H & S Technical Services | H&S-CONDUCTIVITY STANDARD SOLUTION | 2004-07-02 | 15 |
| K033330 | Mesa Laboratories, Inc. | CONDUCTIVITY/TDS CALIBRATOR SOLUTION | 2004-02-27 | 134 |
| K032075 | Ibp Instruments GmbH | CONDUCTIVITY STANDARD SOLUTION-METERCARE | 2003-09-17 | 72 |
Recalls for FKH devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-12-12.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code FKH?
FKH is the FDA product code for solution-test standard-conductivity, dialysis. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FKH?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FKH?
Across 8 cleared submissions the average was 60 days from receipt to decision (median 65).
Which companies have the most FKH clearances?
Mesa Laboratories, Inc. (3); H & S Technical Services (1); Ibp Instruments GmbH (1); D.R.G. Scientific Industries (1); Rna Medical Corp. (1).
Have FKH devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-12-12.
Next steps
- Run an FDA pathway report with predicate devices for product code FKH
- Run a recall and safety report across every FKH manufacturer
- Watch product code FKH 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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