← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

LKK — Pump, Infusion, Implanted, Programmable

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
HO
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
pma: 4
0
RECALL ENTRIES

Recent clearances

P890055Intera Oncology · pma2026-03-16
P860004Medtronic, Inc. · pma2026-02-12
P080012Infusyn Therapeutics, LLC · pma2025-06-18
P990034Medtronic, Inc. · pma2024-11-22

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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