← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

FIP — Subsystem, Water Purification

DEVICE CLASS
Class II
REGULATION
21 CFR 876.5665
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K250471Fresenius Medical Care Renal Therapies Group, LLC · 510k2025-11-14
K251851Fresenius Medical Care Renal Therapies Group, LLC · 510k2025-10-09
K252181Fresenius Medical Care North America · 510k2025-09-09
K250514Specialty Water Technologies, Inc. · 510k2025-03-17

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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