510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081515Substantially Equivalent

Neomed Dual Lumen Umbilical Catheter, Models S2uvc4.0, S2uvc5.0

Halyard Health, Swanee GA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081515 is the FDA 510(k) clearance record for NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0, a class II device, cleared for Neomed, Inc. on under FDA product code FOS (Catheter, Umbilical Artery). FDA records list 96 510(k) clearances for Halyard Health, from to . As of , FDA records show no recalls naming K081515.

Clearance record

Decision date
Received
(52 days to decision)
Product code
FOS Catheter, Umbilical Artery
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Neomed, Inc. 717 Lakeglen Dr., Swanee GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FOS

Trailing 12 months

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

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