510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083121Substantially Equivalent

Neo Mapcath Sensor Stylet

Halyard Health, Wheeling IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K083121 is the FDA 510(k) clearance record for NEO MAPCATH SENSOR STYLET, a class II device, cleared for Corpak Medsystems on under FDA product code OMF (Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position). FDA's definition for product code OMF reads: "When used in connection with a locator instrument is designed to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure". FDA records list 96 510(k) clearances for Halyard Health, from to . As of , FDA records show no recalls naming K083121.

Clearance record

Decision date
Received
(112 days to decision)
Product code
OMF Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
Regulation
21 CFR 880.5970
Device class
Class II
Review panel
General Hospital
Applicant
Corpak Medsystems 100 Chaddick Dr., Wheeling IL
510(k) summary
Statement
Third party review
No

Clearances, product code OMF

Trailing 12 months

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

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