FDA product code CCX: Support, Patient Position
CCX is the FDA product code for support, patient position. It is a Class I device, regulated under 21 CFR 868.6820 and reviewed by the Anesthesiology panel. FDA has cleared 8 510(k) submissions under CCX, from 8 different applicants. The average 510(k) review took 45 days (median 30). FDA has posted 7 recalls for CCX devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Support, Patient Position |
| Device class | Class I |
| Regulation | 21 CFR 868.6820 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CCX clearance
Top CCX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edward Carden | 1 | 1994-10-14 |
| Sharn, Inc. | 1 | 1993-10-05 |
| American Medical Development, Inc. | 1 | 1993-10-01 |
| Treace Medical, Inc. | 1 | 1986-05-30 |
| Scientific Sales Intl., Inc. | 1 | 1983-10-14 |
3 more applicants have CCX clearances. See the full list in Caduvo.
Most recent CCX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K943837 | Edward Carden | CHIN UP | 1994-10-14 | 70 |
| K932305 | Sharn, Inc. | VILA-COOKE(TM) ANESTHESIA PILLOW | 1993-10-05 | 146 |
| K934235 | American Medical Development, Inc. | SNIFF POSITION PILLOW | 1993-10-01 | 32 |
| K861915 | Treace Medical, Inc. | SURGICAL HEAD SUPPORT | 1986-05-30 | 11 |
| K833022 | Scientific Sales Intl., Inc. | AIR UTERINE DISPLACER-AUD 120 | 1983-10-14 | 38 |
Recalls for CCX devices
7 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-04-08.
| Year | Recalls |
|---|---|
| 2021 | 3 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code CCX?
CCX is the FDA product code for support, patient position. It is a Class I device, regulated under 21 CFR 868.6820 and reviewed by the Anesthesiology panel.
What device class is CCX?
Class I, regulation 21 CFR 868.6820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CCX?
Across 8 cleared submissions the average was 45 days from receipt to decision (median 30).
Which companies have the most CCX clearances?
Edward Carden (1); Sharn, Inc. (1); American Medical Development, Inc. (1); Treace Medical, Inc. (1); Scientific Sales Intl., Inc. (1).
Have CCX devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2024-04-08.
Next steps
- Run an FDA pathway report with predicate devices for product code CCX
- Run a recall and safety report across every CCX manufacturer
- Watch product code CCX 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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