510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870395Substantially Equivalent

Churchill Parenteral Nutrition Bag - Eva

Churchill Corp., Langhorne PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870395 is the FDA 510(k) clearance record for CHURCHILL PARENTERAL NUTRITION BAG - EVA, a class II device, cleared for Churchill Corp. on under FDA product code KPE (Container, I.V.). FDA records list 35 510(k) clearances for Churchill Corp., from to . As of , FDA records show no recalls naming K870395.

Clearance record

Decision date
Received
(258 days to decision)
Product code
KPE Container, I.V.
Regulation
21 CFR 880.5025
Device class
Class II
Review panel
General Hospital
Applicant
Churchill Corp. One Summit Sq., Langhorne PA
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