FDA product code JKS: Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
JKS is the FDA product code for spectral absorb. curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide. It is a Class I device, regulated under 21 CFR 862.3220 and reviewed by the Clinical Toxicology panel. FDA has cleared 8 510(k) submissions under JKS, from 8 different applicants. The average 510(k) review took 90 days (median 84). FDA has posted 1 recall for JKS devices.
Classification
| Field | Value |
|---|---|
| Device name | Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide |
| Device class | Class I |
| Regulation | 21 CFR 862.3220 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JKS clearance
Top JKS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| A-Vox Systems, Inc. | 1 | 1995-11-06 |
| D.R.G. Scientific Industries | 1 | 1986-11-24 |
| Instrumentation Laboratory CO | 1 | 1986-07-29 |
| Radiometer America, Inc. | 1 | 1985-12-30 |
| Shaban Mfg. Co. | 1 | 1983-12-30 |
3 more applicants have JKS clearances. See the full list in Caduvo.
Most recent JKS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K951485 | A-Vox Systems, Inc. | AVOXIMETER 4000 | 1995-11-06 | 221 |
| K863825 | D.R.G. Scientific Industries | CO-OXIMETER SOLUTIONS | 1986-11-24 | 55 |
| K862253 | Instrumentation Laboratory CO | IL 482 CO-OXIMETER | 1986-07-29 | 46 |
| K853990 | Radiometer America, Inc. | OSM3 HEMOXIMETER | 1985-12-30 | 94 |
| K833693 | Shaban Mfg. Co. | TEE ADAPTER 9890-FLUSH WINDING 282 | 1983-12-30 | 73 |
Recalls for JKS devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-02-13.
Frequently asked questions
What is FDA product code JKS?
JKS is the FDA product code for spectral absorb. curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide. It is a Class I device, regulated under 21 CFR 862.3220 and reviewed by the Clinical Toxicology panel.
What device class is JKS?
Class I, regulation 21 CFR 862.3220. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JKS?
Across 8 cleared submissions the average was 90 days from receipt to decision (median 84).
Which companies have the most JKS clearances?
A-Vox Systems, Inc. (1); D.R.G. Scientific Industries (1); Instrumentation Laboratory CO (1); Radiometer America, Inc. (1); Shaban Mfg. Co. (1).
Have JKS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-02-13.
Next steps
- Run an FDA pathway report with predicate devices for product code JKS
- Run a recall and safety report across every JKS manufacturer
- Watch product code JKS 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.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times