FDA product code LKK: Pump, Infusion, Implanted, Programmable
LKK is the FDA product code for pump, infusion, implanted, programmable. It is a Class III device, reviewed by the General Hospital panel. Devices under LKK reach the market by PMA; FDA lists no cleared 510(k)s for it. 6 PMA applications cite this product code. FDA has posted 132 recalls for LKK devices, 12 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Pump, Infusion, Implanted, Programmable |
| Device class | Class III |
| Review panel | HO — General Hospital |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for LKK devices
132 product recalls in 55 recall events; 12 initiated in the last five years and 17 still open. Most recent: 2026-05-11.
| Year | Recalls |
|---|---|
| 2017 | 4 |
| 2018 | 1 |
| 2019 | 12 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 6 |
| 2025 | 1 |
| 2026 | 2 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter)
- A4220 — Refill kit for implantable infusion pump
- E0783 — Infusion pump system, implantable, programmable (includes all components, e.g., pump, catheter, connectors, etc.)
- E0782 — Infusion pump, implantable, non-programmable (includes all components, e.g., pump, catheter, connectors, etc.)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement
Frequently asked questions
What is FDA product code LKK?
LKK is the FDA product code for pump, infusion, implanted, programmable. It is a Class III device, reviewed by the General Hospital panel.
What device class is LKK?
Class III. Typical premarket route: PMA.
Have LKK devices been recalled?
Yes: 132 product recalls across 55 recall events; the most recent began 2026-05-11.
Next steps
- Run an FDA pathway report with predicate devices for product code LKK
- Run a recall and safety report across every LKK manufacturer
- Watch product code LKK 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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