FDA product code CBL: Absorbent, Carbon-Dioxide
CBL is the FDA product code for absorbent, carbon-dioxide. It is a Class I device, regulated under 21 CFR 868.5300 and reviewed by the Anesthesiology panel. FDA has cleared 5 510(k) submissions under CBL, from 5 different applicants. The average 510(k) review took 77 days (median 64). FDA has posted 7 recalls for CBL devices.
Classification
| Field | Value |
|---|---|
| Device name | Absorbent, Carbon-Dioxide |
| Device class | Class I |
| Regulation | 21 CFR 868.5300 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Top CBL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Molecular Products , Ltd. | 1 | 1992-10-15 |
| Gibeck, Inc. | 1 | 1990-03-13 |
| Dentsply Intl. | 1 | 1986-02-28 |
| Medipart Jerry Alexander | 1 | 1985-10-29 |
| Allied Healthcare Products, Inc. | 1 | 1981-05-27 |
Most recent CBL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K921803 | Molecular Products , Ltd. | SOFNOLIME CARBON DIOXIDE ABSORBENT | 1992-10-15 | 183 |
| K897171 | Gibeck, Inc. | DISPOSABLE CO2 ABSORBER/E | 1990-03-13 | 75 |
| K860147 | Dentsply Intl. | CARBON DIOXIDE ABSORBENTS | 1986-02-28 | 44 |
| K853571 | Medipart Jerry Alexander | MEDIPART SODA LIME MP-3522 | 1985-10-29 | 64 |
| K811260 | Allied Healthcare Products, Inc. | BARALYME CO2 ABSORBENT | 1981-05-27 | 21 |
Recalls for CBL devices
7 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-08-05.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code CBL?
CBL is the FDA product code for absorbent, carbon-dioxide. It is a Class I device, regulated under 21 CFR 868.5300 and reviewed by the Anesthesiology panel.
What device class is CBL?
Class I, regulation 21 CFR 868.5300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CBL?
Across 5 cleared submissions the average was 77 days from receipt to decision (median 64).
Which companies have the most CBL clearances?
Molecular Products , Ltd. (1); Gibeck, Inc. (1); Dentsply Intl. (1); Medipart Jerry Alexander (1); Allied Healthcare Products, Inc. (1).
Have CBL devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2021-08-05.
Next steps
- Run an FDA pathway report with predicate devices for product code CBL
- Run a recall and safety report across every CBL manufacturer
- Watch product code CBL 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.