FILTRAL HEMODIALYZER— 510(k) K852885

Name: FDA 510(k) clearance K852885
Creator: U.S. Food and Drug Administration
Published: 1985-09-06

Substantially Equivalent

Hospal Medical Corp.

FDA 510(k) clearance K852885 for FILTRAL HEMODIALYZER, Substantially Equivalent on 1985-09-06. Applicant: Hospal Medical Corp.. Device class: 2.

Clearance details

Applicant: Hospal Medical Corp.
Product code: Code KDI
Device class: Class 2
Regulation: 21 CFR 876.5860
Advisory panel: Gastroenterology, Urology
Date received: 1985-07-09
Decision date: 1985-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Brunswick, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Hospal Medical Corp.

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K893742 — FILTRAL TM 20 HEMODIALYZER/FILTER1989-07-24
K884365 — MULTIFLOW(TM) 60 KIT1988-12-08
K884326 — FILTRAL TM 8 HEMODIALYZER1988-12-05
K883307 — CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT1988-10-12
K872767 — FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER1987-12-29

Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.