FKH
8 FDA 510(k) clearances · Product code
69 daysmedian time to decision
134 days90th percentile
8clearances measured
FDA profile
- Official device name
- Solution-Test Standard-Conductivity, Dialysis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2002: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TDS Standard Solution (K191496) | Mesa Laboratories, Inc. | 2019-08-05 |
| COMINED STANDARD SOLUTION (K130100) | Mesa Laboratories, Inc. | 2013-04-18 |
| H&S-CONDUCTIVITY STANDARD SOLUTION (K041636) | H & S Technical Services | 2004-07-02 |
| CONDUCTIVITY/TDS CALIBRATOR SOLUTION (K033330) | Mesa Laboratories, Inc. | 2004-02-27 |
| CONDUCTIVITY STANDARD SOLUTION-METERCARE (K032075) | Ibp Instruments GmbH | 2003-09-17 |
| SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT. (K863824) | D.R.G. Scientific Industries | 1986-10-24 |
| STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF (K851362) | Rna Medical Corp. | 1985-06-12 |
| HEMODIALYSIS VENOUS & ARTERIAL SET (K812622) | Amisco Trading Corp. | 1981-09-24 |
Track FKH automatically
Every clearance here is in the API, with alerts when new ones post.