FDA product code KNR: Adapter, A-V Shunt Or Fistula
KNR is the FDA product code for adapter, a-v shunt or fistula. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under KNR. The average 510(k) review took 61 days (median 61).
Classification
| Field | Value |
|---|---|
| Device name | Adapter, A-V Shunt Or Fistula |
| Device class | Class II |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every KNR clearance
Top KNR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dravon Medical, Inc. | 1 | 1981-08-31 |
Most recent KNR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K811851 | Dravon Medical, Inc. | S-610 SHUNT ADAPTOR SET | 1981-08-31 | 61 |
Recalls for KNR devices
openFDA lists no recalls for product code KNR.
Frequently asked questions
What is FDA product code KNR?
KNR is the FDA product code for adapter, a-v shunt or fistula. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is KNR?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
How long does a 510(k) take for product code KNR?
Across 1 cleared submissions the average was 61 days from receipt to decision (median 61).
Which companies have the most KNR clearances?
Dravon Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KNR
- Run a recall and safety report across every KNR manufacturer
- Watch product code KNR 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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