FDA product code KGK: Gas, Collecting Vessel
KGK is the FDA product code for gas, collecting vessel. It is a Class I device, regulated under 21 CFR 868.1575 and reviewed by the Anesthesiology panel. FDA has cleared 2 510(k) submissions under KGK, from 2 different applicants. The average 510(k) review took 31 days (median 31).
Classification
| Field | Value |
|---|---|
| Device name | Gas, Collecting Vessel |
| Device class | Class I |
| Regulation | 21 CFR 868.1575 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KGK clearance
Top KGK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Respironics, Inc. | 1 | 1986-10-15 |
| Instrumentation Industries, Inc. | 1 | 1977-04-08 |
Most recent KGK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863171 | Respironics, Inc. | RESPIRONICS PROTECTEASY | 1986-10-15 | 58 |
| K770632 | Instrumentation Industries, Inc. | GAS COLLHCTOR BE 155(155-2-3,154-4) | 1977-04-08 | 4 |
Recalls for KGK devices
openFDA lists no recalls for product code KGK.
Frequently asked questions
What is FDA product code KGK?
KGK is the FDA product code for gas, collecting vessel. It is a Class I device, regulated under 21 CFR 868.1575 and reviewed by the Anesthesiology panel.
What device class is KGK?
Class I, regulation 21 CFR 868.1575. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KGK?
Across 2 cleared submissions the average was 31 days from receipt to decision (median 31).
Which companies have the most KGK clearances?
Respironics, Inc. (1); Instrumentation Industries, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KGK
- Run a recall and safety report across every KGK manufacturer
- Watch product code KGK 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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