510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K812852Substantially Equivalent

Set for Aseptic Decanting of a Flex i.v

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

K812852 is the FDA 510(k) clearance record for SET FOR ASEPTIC DECANTING OF A FLEX I.V, a class II device, cleared for Dip, Inc. on under FDA product code KPE (Container, I.V.). FDA records list one 510(k) clearance for Dip, Inc. As of , FDA records show no recalls naming K812852.

Clearance record

Decision date
Received
(20 days to decision)
Product code
KPE Container, I.V.
Regulation
21 CFR 880.5025
Device class
Class II
Review panel
General Hospital
Applicant
Dip, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KPE

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