510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820173Substantially Equivalent

Cobe Single-Needle Controller #18-756

Cobe Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820173 is the FDA 510(k) clearance record for COBE SINGLE-NEEDLE CONTROLLER #18-756, a class II device, cleared for Cobe Laboratories, Inc. on under FDA product code FIF (Set, Dialysis, Single Needle With Uni-Directional Pump). FDA records list 77 510(k) clearances for Cobe Laboratories, Inc., from to . As of , FDA records show no recalls naming K820173.

Clearance record

Decision date
Received
(61 days to decision)
Product code
FIF Set, Dialysis, Single Needle With Uni-Directional Pump
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cobe Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FIF

Trailing 12 months

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

FDA records show no clearances under product code FIF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FIF, 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