510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895366Substantially Equivalent

Enteral Pump Set with Entera (Tm)-Flo Spike

Fresenius USA, Inc., New Brunswick NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895366 is the FDA 510(k) clearance record for ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE, a class II device, cleared for Fresenius USA, Inc. on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list 38 510(k) clearances for Fresenius USA, Inc., from to . As of , FDA records show no recalls naming K895366.

Clearance record

Decision date
Received
(247 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fresenius USA, Inc. 120 Albany St., New Brunswick NJ
Third party review
No

Clearances, product code KNT

Trailing 12 months
2 clearances under product code KNT in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260