510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K151628Substantially Equivalent

Medline ENFit Connectors

MEDLINE INDUSTRIES, LP - Northfield, Mundelein IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151628 is the FDA 510(k) clearance record for Medline ENFit Connectors, a class II device, cleared for Medline Industries, Inc. on under FDA product code PIO (Enteral Specific Transition Connectors). FDA's definition for product code PIO reads: "Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors". FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show one recall naming K151628.

Clearance record

Decision date
Received
(37 days to decision)
Product code
PIO Enteral Specific Transition Connectors
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Medline Industries, Inc. One Medline Pl., Mundelein IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PIO

Trailing 12 months

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

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