CBL · Absorbent, Carbon-Dioxide
Anesthesiology · 21 CFR 868.5300 · Class 1
Overview
| Product Code | CBL |
|---|---|
| Device Name | Absorbent, Carbon-Dioxide |
| Regulation | 21 CFR 868.5300 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A carbon dioxide absorbent is a device intended for medical purposes that consists of an absorbent material (e.g., soda lime) that is intended to remove carbon dioxide from the gases in the breathing circuit.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Cleared Devices (5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K921803 | SOFNOLIME CARBON DIOXIDE ABSORBENT | Molecular Products , Ltd. | Oct 15, 1992 | SESE |
| K897171 | DISPOSABLE CO2 ABSORBER/E | Gibeck, Inc. | Mar 13, 1990 | SESE |
| K860147 | CARBON DIOXIDE ABSORBENTS | Dentsply Intl. | Feb 28, 1986 | SESE |
| K853571 | MEDIPART SODA LIME MP-3522 | Medipart Jerry Alexander | Oct 29, 1985 | SESE |
| K811260 | BARALYME CO2 ABSORBENT | Allied Healthcare Products, Inc. | May 27, 1981 | SESE |
Top Applicants
- Molecular Products , Ltd. — 1 clearance
- Medipart Jerry Alexander — 1 clearance
- Gibeck, Inc. — 1 clearance
- Dentsply Intl. — 1 clearance
- Allied Healthcare Products, Inc. — 1 clearance
