Chrysalis Intelligence · Sponsors · Kaneka Pharma America, LLC

Kaneka Pharma America, LLC

New York, NY, US · 1 510(k) clearances · 16 PMAs

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Total clearances
1
2020-04-25 → 2020-04-25
Last 12 months
0
Product codes
1
Most recent
2020-04-25
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
HCG — — — 1 2020-04-25
Class III

PMA approvals (16)

Total PMA records
16
Originals + supplements
Distinct product codes
1
First decision
2020-04-21
Most recent
2026-06-16
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-06-16 P910018-S042 LIPOSORBER® LA-15 System 30-Day Notice MMY Lipoprotein, Low Density, Removal Unknown
2026-03-30 P910018-S041 LIPOSORBER® LA-15 System Real-Time Process MMY Lipoprotein, Low Density, Removal Unknown
2025-03-05 P910018-S037 LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2). Normal 180 Day Track MMY Lipoprotein, Low Density, Removal Unknown
2025-01-24 P910018-S039 LIPOSORBER® LA-15 System Normal 180 Day Track MMY Lipoprotein, Low Density, Removal Unknown
2025-01-15 P910018-S036 LIPOSORBER® LA-15 System Normal 180 Day Track No User Fee MMY Lipoprotein, Low Density, Removal Unknown
2024-09-26 P910018-S040 LIPOSORBER LA-15 System 30-Day Notice MMY Lipoprotein, Low Density, Removal Unknown
2024-08-27 P910018-S038 LIPOSORBER® LA-15 System 30-Day Notice MMY Lipoprotein, Low Density, Removal Unknown
2023-03-01 P910018-S035 LIPOSORBER LA-15 System 30-Day Notice MMY Lipoprotein, Low Density, Removal Unknown
2022-06-30 P910018-S034 LIPOSORBER LA-15 System 30-Day Notice MMY Lipoprotein, Low Density, Removal Unknown
2022-04-29 P910018-S033 LIPOSORBER LA-15 System 30-Day Notice MMY Lipoprotein, Low Density, Removal Unknown
2022-01-14 P910018-S032 LIPOSORBER LA-15 System Special (Immediate Track) MMY Lipoprotein, Low Density, Removal Unknown
2021-08-06 P910018-S029 LIPOSORBER LA-15 System 135 Review Track For 30-Day Notice MMY Lipoprotein, Low Density, Removal Unknown
2021-07-28 P910018-S031 LIPOSORBER LA-15 System 30-Day Notice MMY Lipoprotein, Low Density, Removal Unknown
2021-04-29 P910018-S030 LIPOSORBER® LA-15 System 30-Day Notice MMY Lipoprotein, Low Density, Removal Unknown
2020-12-22 P910018-S028 LIPOSORBER LA-15 System 30-Day Notice MMY Lipoprotein, Low Density, Removal Unknown
2020-04-21 P910018-S027 LIPOSORBER LA-15 System Normal 180 Day Track MMY Lipoprotein, Low Density, Removal Unknown
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2020-04-25 K192068 i-ED COIL HCG — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence