510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K873279Substantially Equivalent

8810 Pump-Pump Single Needle Device

Cd Medical, Inc., Portland OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K873279 is the FDA 510(k) clearance record for 8810 PUMP-PUMP SINGLE NEEDLE DEVICE, a class II device, cleared for Cd Medical, Inc. on under FDA product code FIF (Set, Dialysis, Single Needle With Uni-Directional Pump). FDA records list 11 510(k) clearances for Cd Medical, Inc., from to . As of , FDA records show no recalls naming K873279.

Clearance record

Decision date
Received
(67 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
Cd Medical, Inc. 13520 SE Pheasant Ct., Portland OR
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