FDA product code FOA: Board, Cardiopulmonary
FOA is the FDA product code for board, cardiopulmonary. It is a Class I device, regulated under 21 CFR 880.6080 and reviewed by the General Hospital panel. FDA has cleared 3 510(k) submissions under FOA, 1 in the last five years, from 3 different applicants. The average 510(k) review took 102 days (median 45).
Classification
| Field | Value |
|---|---|
| Device name | Board, Cardiopulmonary |
| Device class | Class I |
| Regulation | 21 CFR 880.6080 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
510(k) clearances per year for FOA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 233 |
| 2022 | 1 | 29 |
Top FOA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advancedcpr Solutions, LLC | 1 | 2022-07-29 |
| Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio | 1 | 2020-02-13 |
| Gillco, Inc. | 1 | 1981-07-02 |
Most recent FOA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221901 | Advancedcpr Solutions, LLC | EleGARD | 2022-07-29 | 29 |
| K191689 | Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio | EleGARD Patient Positioning System | 2020-02-13 | 233 |
| K811397 | Gillco, Inc. | ECA | 1981-07-02 | 45 |
Recalls for FOA devices
openFDA lists no recalls for product code FOA.
Frequently asked questions
What is FDA product code FOA?
FOA is the FDA product code for board, cardiopulmonary. It is a Class I device, regulated under 21 CFR 880.6080 and reviewed by the General Hospital panel.
What device class is FOA?
Class I, regulation 21 CFR 880.6080. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FOA?
Across 3 cleared submissions the average was 102 days from receipt to decision (median 45).
Which companies have the most FOA clearances?
Advancedcpr Solutions, LLC (1); Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio (1); Gillco, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FOA
- Run a recall and safety report across every FOA manufacturer
- Watch product code FOA 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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