Product code KMA— Ear, Nose, Throat

FDA has cleared 5 devices under product code KMA between 1982 and 2014, filed by 4 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.

• 20141 clearance
• 19981 clearance
• 19961 clearance
• 19951 clearance
• 19821 clearance

• Respironics, Inc.2 clearances
• Rhinosystems, Inc.1 clearance
• Kelleher Corp.1 clearance
• Jedmed Instrument Co.1 clearance

• K140542 — NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANERRhinosystems, Inc.·2014-06-27
• K973875 — RINOFLOW MICRONIZED E.N.T. WASH SYSTEMRespironics, Inc.·1998-01-26
• K963550 — RINOFLOW MICRONIZED E.N..T. WASH SYTSTEMRespironics, Inc.·1996-11-01
• K950078 — MICROFLOW IRRIGATION SYSTEMJedmed Instrument Co.·1995-06-21
• K822351 — POWDER BLOWERSKelleher Corp.·1982-09-14