FDA product code KPK: Marker, Ostia, Aorto-Saphenous Vein
KPK is the FDA product code for marker, ostia, aorto-saphenous vein. It is a Class II device, regulated under 21 CFR 878.4650 and reviewed by the Cardiovascular panel. FDA has cleared 6 510(k) submissions under KPK, from 6 different applicants. The average 510(k) review took 68 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Marker, Ostia, Aorto-Saphenous Vein |
| Device class | Class II |
| Regulation | 21 CFR 878.4650 |
| Review panel | CV — Cardiovascular |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every KPK clearance
Top KPK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Med-Edge, Inc. | 1 | 1998-01-26 |
| Voss Medical Products | 1 | 1989-09-27 |
| Scanlan Intl., Inc. | 1 | 1987-01-12 |
| Cook, Inc. | 1 | 1986-10-30 |
| C.R. Bard, Inc. | 1 | 1980-08-27 |
1 more applicants have KPK clearances. See the full list in Caduvo.
Most recent KPK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971966 | Med-Edge, Inc. | CORONARY VEIN GRAFT TAG MARKER | 1998-01-26 | 243 |
| K895369 | Voss Medical Products | VOSS GRAFT MARKER | 1989-09-27 | 29 |
| K864919 | Scanlan Intl., Inc. | SCANLAN (TM) VEIN/GRAFT HOLDER | 1987-01-12 | 27 |
| K864101 | Cook, Inc. | COOK (R) VEIN GRAFT RING MARKERS | 1986-10-30 | 9 |
| K801637 | C.R. Bard, Inc. | FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. | 1980-08-27 | 41 |
Recalls for KPK devices
openFDA lists no recalls for product code KPK.
Frequently asked questions
What is FDA product code KPK?
KPK is the FDA product code for marker, ostia, aorto-saphenous vein. It is a Class II device, regulated under 21 CFR 878.4650 and reviewed by the Cardiovascular panel.
What device class is KPK?
Class II, regulation 21 CFR 878.4650. Typical premarket route: 510(k).
How long does a 510(k) take for product code KPK?
Across 6 cleared submissions the average was 68 days from receipt to decision (median 35).
Which companies have the most KPK clearances?
Med-Edge, Inc. (1); Voss Medical Products (1); Scanlan Intl., Inc. (1); Cook, Inc. (1); C.R. Bard, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KPK
- Run a recall and safety report across every KPK manufacturer
- Watch product code KPK 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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