MINIFILTER HEMOFILTER— 510(k) K853510

Name: FDA 510(k) clearance K853510
Creator: U.S. Food and Drug Administration
Published: 1985-09-12

Substantially Equivalent

Amicon, Inc.

FDA 510(k) clearance K853510 for MINIFILTER HEMOFILTER, Substantially Equivalent on 1985-09-12. Applicant: Amicon, Inc.. Device class: 2.

Clearance details

Applicant: Amicon, Inc.
Product code: Code KDI
Device class: Class 2
Regulation: 21 CFR 876.5860
Advisory panel: Gastroenterology, Urology
Date received: 1985-08-21
Decision date: 1985-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

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K930168 — CENTRICON -50 CONCENTRATOR1993-08-05
K902837 — AMICON DIAFILTER 30 HEMOCONCENTRATOR1990-11-01
K901286 — AMICON HEMOCONCENTRATOR SET1990-05-18
K900280 — CENTRIPREP 1001990-02-16
K895405 — AMICON MINIFILTER PLUS HEMOFILTER1990-01-11

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.