Product code FKJ— Gastroenterology, Urology

FDA has cleared 5 devices under product code FKJ between 1977 and 2026, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20261 clearance
• 19901 clearance
• 19841 clearance
• 19821 clearance
• 19771 clearance

• Terumo America, Inc.1 clearance
• Serim Research Corp.1 clearance
• Serim Research1 clearance
• Computer Dialysis Systems, Inc.1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance

• K253863 — GUARDIAN Quick Dip Residual Chlorine (5212)Serim Research·2026-03-17
• K901734 — SERIM RESIDUAL CHLORINE TEST KITSerim Research Corp.·1990-09-13
• K841307 — BBL GASPAK POUCHBd Becton Dickinson Vacutainer Systems Preanalytic·1984-05-14
• K820575 — J.E.T. DIALYSIS SYSTEMComputer Dialysis Systems, Inc.·1982-05-20
• K772040 — TRANSDUCER PROTECTORTerumo America, Inc.·1977-11-28