FDA product code DYC: Vectorcardiograph
DYC is the FDA product code for vectorcardiograph. It is a Class II device, regulated under 21 CFR 870.2400 and reviewed by the Cardiovascular panel. FDA has cleared 4 510(k) submissions under DYC, from 4 different applicants. The average 510(k) review took 225 days (median 212).
Classification
| Field | Value |
|---|---|
| Device name | Vectorcardiograph |
| Device class | Class II |
| Regulation | 21 CFR 870.2400 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DYC clearance
Top DYC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ortivus AB | 1 | 2003-12-05 |
| Medical Graphics Corp. | 1 | 1990-01-18 |
| Odam | 1 | 1983-12-16 |
| Elmed, Inc. | 1 | 1981-04-23 |
Most recent DYC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023414 | Ortivus AB | MIDA ALGORITHM REV. B | 2003-12-05 | 420 |
| K896396 | Medical Graphics Corp. | MIDA SYSTEM, MODELS 1000/1100 | 1990-01-18 | 73 |
| K823934 | Odam | CARIEL F12 | 1983-12-16 | 352 |
| K810529 | Elmed, Inc. | DIRECT WRITING VECTORCARDIOGRAPH | 1981-04-23 | 56 |
Recalls for DYC devices
openFDA lists no recalls for product code DYC.
Frequently asked questions
What is FDA product code DYC?
DYC is the FDA product code for vectorcardiograph. It is a Class II device, regulated under 21 CFR 870.2400 and reviewed by the Cardiovascular panel.
What device class is DYC?
Class II, regulation 21 CFR 870.2400. Typical premarket route: 510(k).
How long does a 510(k) take for product code DYC?
Across 4 cleared submissions the average was 225 days from receipt to decision (median 212).
Which companies have the most DYC clearances?
Ortivus AB (1); Medical Graphics Corp. (1); Odam (1); Elmed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DYC
- Run a recall and safety report across every DYC manufacturer
- Watch product code DYC 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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