510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K923168Substantially Equivalent

Dual Port Enteral Y-Adaptor

Orion Life Systems, Inc., Wheeling IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923168 is the FDA 510(k) clearance record for DUAL PORT ENTERAL Y-ADAPTOR, a class II device, cleared for Orion Life Systems, Inc. on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list 33 510(k) clearances for Orion Life Systems, Inc., from to . As of , FDA records show no recalls naming K923168.

Clearance record

Decision date
Received
(718 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Orion Life Systems, Inc. 124 Messner Dr., Wheeling IL
510(k) summary
Statement
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