Product Code: KGK FDA class 1 21 CFR 868.1575

Gas, Collecting Vessel

Anesthesiology

Gas Collecting Vessel is a device used in anesthesiology or respiratory monitoring to collect gas samples from a patient's breathing circuit or the surrounding environment, allowing subsequent analysis of gas composition for clinical assessment or equipment monitoring. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KGK, regulated under 21 CFR 868.1575, within the Anesthesiology medical specialty.

510(k)s
2
FEI Numbers
11
Registration Numbers
11
Unique Applicants
2
Years Active
10

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Basic Information

Product Code
KGK
Device Class
FDA class 1
Regulation Number
868.1575
Medical Specialty
Anesthesiology
Review Panel
AN
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K863171 RESPIRONICS PROTECTEASY
K770632 GAS COLLHCTOR BE 155(155-2-3,154-4)

FEI Numbers

This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.