← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

FPA — Set, Administration, Intravascular

DEVICE CLASS
Class II
REGULATION
21 CFR 880.5440
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
16
510(K)/PMA CLEARANCES
510k: 16
0
RECALL ENTRIES

Recent clearances

K261530Deka Research and Development · 510k2026-06-03
K252543Amsino International, Inc. · 510k2026-05-04
K251375Puracath Medical, Inc. · 510k2026-02-12
K251257Np Medical · 510k2025-12-04
K250325Carefusion (Bd) · 510k2025-10-30
K251814Epic Medical Pte. , Ltd. · 510k2025-08-29
K251854Tandem Diabetes Care · 510k2025-08-06
K243841Deka Research and Development · 510k2025-08-01

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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