FDA product code CBO: Attachment, Intermittent Mandatory Ventilation (Imv)
CBO is the FDA product code for attachment, intermittent mandatory ventilation (imv). It is a Class II device, regulated under 21 CFR 868.5955 and reviewed by the Anesthesiology panel. FDA has cleared 15 510(k) submissions under CBO, from 9 different applicants. The average 510(k) review took 24 days (median 14).
Classification
| Field | Value |
|---|---|
| Device name | Attachment, Intermittent Mandatory Ventilation (Imv) |
| Device class | Class II |
| Regulation | 21 CFR 868.5955 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every CBO clearance
Top CBO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mem Medical, Inc. | 7 | 1979-10-09 |
| The Lynn Terrell Co. | 1 | 1981-08-12 |
| Airlife, Inc. | 1 | 1981-07-16 |
| Chemetron Medical Products, Inc. | 1 | 1979-01-22 |
| Inspiron Corp. | 1 | 1976-12-09 |
4 more applicants have CBO clearances. See the full list in Caduvo.
Most recent CBO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K811991 | The Lynn Terrell Co. | SIMVAC | 1981-08-12 | 30 |
| K811908 | Airlife, Inc. | IMV MANIFOLDS | 1981-07-16 | 15 |
| K791911 | Mem Medical, Inc. | FALL-SAFE IMV #M-511 | 1979-10-09 | 14 |
| K791906 | Mem Medical, Inc. | IMV W/BAG #M-507 | 1979-10-09 | 14 |
| K791912 | Mem Medical, Inc. | IMV FOR MONITORING #M-510 | 1979-10-09 | 14 |
Recalls for CBO devices
openFDA lists no recalls for product code CBO.
Frequently asked questions
What is FDA product code CBO?
CBO is the FDA product code for attachment, intermittent mandatory ventilation (imv). It is a Class II device, regulated under 21 CFR 868.5955 and reviewed by the Anesthesiology panel.
What device class is CBO?
Class II, regulation 21 CFR 868.5955. Typical premarket route: 510(k).
How long does a 510(k) take for product code CBO?
Across 15 cleared submissions the average was 24 days from receipt to decision (median 14).
Which companies have the most CBO clearances?
Mem Medical, Inc. (7); The Lynn Terrell Co. (1); Airlife, Inc. (1); Chemetron Medical Products, Inc. (1); Inspiron Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CBO
- Run a recall and safety report across every CBO manufacturer
- Watch product code CBO 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.
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