510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K971710Substantially Equivalent

Ultracon Ultrafiltrator

Quantic Biomedical, Inc., San Rafael CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971710 is the FDA 510(k) clearance record for ULTRACON ULTRAFILTRATOR, a class II device, cleared for Quantic Biomedical, Inc. on under FDA product code FJI (Dialyzer, Capillary, Hollow Fiber). FDA records list one 510(k) clearance for Quantic Biomedical, Inc. As of , FDA records show no recalls naming K971710.

Clearance record

Decision date
Received
(295 days to decision)
Product code
FJI Dialyzer, Capillary, Hollow Fiber
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Quantic Biomedical, Inc. 810 "E" St., San Rafael CA
510(k) summary
Summary
Third party review
No

Clearances, product code FJI

Trailing 12 months

FDA records hold no clearances under product code FJI in the trailing twelve months.

FDA records show no clearances under product code FJI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FJI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260