Absorbent, Carbon-Dioxide
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.
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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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K921803 | SOFNOLIME CARBON DIOXIDE ABSORBENT | Oct 15, 1992 | Substantially Equivalent | Molecular Products , Ltd. |
| K897171 | DISPOSABLE CO2 ABSORBER/E | Mar 13, 1990 | Substantially Equivalent | Gibeck, Inc. |
| K860147 | CARBON DIOXIDE ABSORBENTS | Feb 28, 1986 | Substantially Equivalent | Dentsply Intl. |
| K853571 | MEDIPART SODA LIME MP-3522 | Oct 29, 1985 | Substantially Equivalent | Medipart Jerry Alexander |
| K811260 | BARALYME CO2 ABSORBENT | May 27, 1981 | Substantially Equivalent | Allied Healthcare Products, Inc. |
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.