Product Code: CBL FDA class 1 21 CFR 868.5300

Absorbent, Carbon-Dioxide

Anesthesiology

The Carbon-Dioxide Absorbent is an anesthesiology material placed within the anesthesia breathing circuit to chemically react with and remove exhaled carbon dioxide from the recirculating gas mixture, preventing CO2 rebreathing during closed-circuit anesthesia delivery. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CBL, regulated under 21 CFR 868.5300, within the Anesthesiology medical specialty. No special flags apply to this device.

510(k)s
5
FEI Numbers
25
Registration Numbers
25
Unique Applicants
5
Years Active
11

Research product code CBL in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Basic Information

Product Code
CBL
Device Class
FDA class 1
Regulation Number
868.5300
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

Loading...

Related 510(k) Clearances

This FDA classification is associated with 5 510(k) clearances via K numbers.

K Number Device Name
K921803 SOFNOLIME CARBON DIOXIDE ABSORBENT
K897171 DISPOSABLE CO2 ABSORBER/E
K860147 CARBON DIOXIDE ABSORBENTS
K853571 MEDIPART SODA LIME MP-3522
K811260 BARALYME CO2 ABSORBENT

FEI Numbers

This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.