Product code FKI— Gastroenterology, Urology

AMER. BENTLEY HEMOFILTER HOLDER HFH-1

Classification name: Set, Dialyzer Holder
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Total cleared: 3
First cleared: 1980-09-16
Most recent: 1984-10-18

Market context for product code FKI

FDA has cleared 3 devices under product code FKI between 1980 and 1984, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

19841 clearance
19811 clearance
19801 clearance

Top applicants under product code FKI

Renal Devices, Inc.1 clearance
Extracorporeal Medical Specialities, Inc.1 clearance
American Bentley1 clearance

Recent clearances under product code FKI

K843504 — AMER. BENTLEY HEMOFILTER HOLDER HFH-1American Bentley·1984-10-18
K811292 — PARALLEL PLATE DIALYZER HOLDERExtracorporeal Medical Specialities, Inc.·1981-06-02
K802075 — HOLLOW FIBER DIALYZER HOLDERRenal Devices, Inc.·1980-09-16

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