FDA product code PKF: D And C Tray
PKF is the FDA product code for d and c tray. It is a Not classified device, reviewed by the Obstetrics and Gynecology panel. Devices under PKF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for PKF devices, 2 initiated in the last five years.
Definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm . This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Classification
| Field | Value |
|---|---|
| Device name | D And C Tray |
| Device class | Not classified |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Recalls for PKF devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-09-04.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code PKF?
PKF is the FDA product code for d and c tray. It is a Not classified device, reviewed by the Obstetrics and Gynecology panel.
What device class is PKF?
Not classified. Typical premarket route: 510(k) exempt.
Have PKF devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-09-04.
Next steps
- Run an FDA pathway report with predicate devices for product code PKF
- Run a recall and safety report across every PKF manufacturer
- Watch product code PKF 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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