JKS
8 FDA 510(k) clearances · Product code
94 daysmedian time to decision
221 days90th percentile
8clearances measured
FDA profile
- Official device name
- Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3220
- Medical specialty
- Clinical Toxicology
- Adverse events (MAUDE)
- 1994: 1 · 1999: 1 · 2000: 1 · 2001: 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 |
|---|---|---|
| AVOXIMETER 4000 (K951485) | A-Vox Systems, Inc. | 1995-11-06 |
| CO-OXIMETER SOLUTIONS (K863825) | D.R.G. Scientific Industries | 1986-11-24 |
| IL 482 CO-OXIMETER (K862253) | Instrumentation Laboratory CO | 1986-07-29 |
| OSM3 HEMOXIMETER (K853990) | Radiometer America, Inc. | 1985-12-30 |
| TEE ADAPTER 9890-FLUSH WINDING 282 (K833693) | Shaban Mfg. Co. | 1983-12-30 |
| BILE SALTS MIXTURE (K833211) | Acumedia Manufacturers, Inc. | 1983-10-27 |
| CONTROL 282 (K832066) | Bio-Nustics, Inc. | 1983-09-29 |
| HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 (K780652) | The London Co. | 1978-07-27 |
Track JKS automatically
Every clearance here is in the API, with alerts when new ones post.