FDA product code CCM: Plethysmograph, Pressure
CCM is the FDA product code for plethysmograph, pressure. It is a Class II device, regulated under 21 CFR 868.1750 and reviewed by the Anesthesiology panel. FDA has cleared 11 510(k) submissions under CCM, from 8 different applicants. The average 510(k) review took 130 days (median 110).
Classification
| Field | Value |
|---|---|
| Device name | Plethysmograph, Pressure |
| Device class | Class II |
| Regulation | 21 CFR 868.1750 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every CCM clearance
Top CCM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Erich Jaeger, Inc. | 3 | 1986-02-05 |
| Medical Graphics Corp. | 2 | 1995-04-10 |
| Viasys Healthcare GmbH | 1 | 2009-05-18 |
| Erich Jaeger GmbH | 1 | 2003-03-03 |
| Quinton, Inc. | 1 | 1989-06-23 |
3 more applicants have CCM clearances. See the full list in Caduvo.
Most recent CCM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K081823 | Viasys Healthcare GmbH | MASTERSCREEN PAED - BABY BODY | 2009-05-18 | 325 |
| K023796 | Erich Jaeger GmbH | MS PAED-BABY BODY | 2003-03-03 | 110 |
| K943259 | Medical Graphics Corp. | 1085 ULTIMATE E PLETHYSMOGRAPH | 1995-04-10 | 278 |
| K893420 | Quinton, Inc. | MASTERLAB PFT AND MASTERLAB BODY BOX | 1989-06-23 | 57 |
| K853390 | Erich Jaeger, Inc. | INFANT BODY TEST | 1986-02-05 | 176 |
Recalls for CCM devices
openFDA lists no recalls for product code CCM.
Frequently asked questions
What is FDA product code CCM?
CCM is the FDA product code for plethysmograph, pressure. It is a Class II device, regulated under 21 CFR 868.1750 and reviewed by the Anesthesiology panel.
What device class is CCM?
Class II, regulation 21 CFR 868.1750. Typical premarket route: 510(k).
How long does a 510(k) take for product code CCM?
Across 11 cleared submissions the average was 130 days from receipt to decision (median 110).
Which companies have the most CCM clearances?
Erich Jaeger, Inc. (3); Medical Graphics Corp. (2); Viasys Healthcare GmbH (1); Erich Jaeger GmbH (1); Quinton, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CCM
- Run a recall and safety report across every CCM manufacturer
- Watch product code CCM 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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