Product code KYX— General Hospital

FDA has cleared 11 devices under product code KYX between 1976 and 2015, filed by 9 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20151 clearance
• 19981 clearance
• 19951 clearance
• 19831 clearance
• 19803 clearances
• 19791 clearance
• 19781 clearance
• 19771 clearance
• 19761 clearance

• Burron Medical Products, Inc.3 clearances
• Tridak1 clearance
• Sangstat Medical Corp.1 clearance
• Pharmaseal Laboratories1 clearance
• National Patent Development Corp.1 clearance
• Landmark Plastics1 clearance
• Kleengel, LLC1 clearance
• Canyon Medical Products1 clearance
• Baxa Corp., Sub. of Cook Group, Inc.1 clearance

Death

3

Other

8

Total

11

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K143177 — KleenGel DispenserKleengel, LLC·2015-09-14
• K980109 — CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSERSangstat Medical Corp.·1998-08-18
• K954181 — CANYONS BI-DIRECTIONAL CHECK VALVECanyon Medical Products·1995-11-29
• K830571 — BOTTLE ADAPTERBurron Medical Products, Inc.·1983-03-24
• K801008 — MULTI-AD FLUID DISPENSING PUMP MP-3000Burron Medical Products, Inc.·1980-06-02
• K800362 — FLUID DISPENSING SYSTEMPharmaseal Laboratories·1980-03-12
• K800437 — SYRINGE TIP CONNECTORBurron Medical Products, Inc.·1980-03-12
• K792227 — MULTI-AD FLUID DISPENSING SYSTEMNational Patent Development Corp.·1979-12-20
• K781364 — PINT BOTTLE WELLBaxa Corp., Sub. of Cook Group, Inc.·1978-10-17
• K771539 — STEPPERTridak·1977-10-07
• K760517 — CUP, DISPOSABLE MEDICINELandmark Plastics·1976-11-12