Product code KSR— Hematology

FDA has cleared 16 devices under product code KSR between 1977 and 2003, filed by 12 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.

• 20031 clearance
• 20021 clearance
• 19816 clearances
• 19803 clearances
• 19792 clearances
• 19782 clearances
• 19771 clearance

• Haemonetics Corp.3 clearances
• Travenol Laboratories, S.A.2 clearances
• Delmed, Inc.2 clearances
• Tyco Healthcare1 clearance
• Terumo America, Inc.1 clearance
• Pharmachem Corp.1 clearance
• North American Biologicals, Inc.1 clearance
• Gambro, Inc.1 clearance
• Dravon Medical, Inc.1 clearance
• Deroyal1 clearance

• K032827 — KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501Tyco Healthcare·2003-12-08
• K020753 — DEROYAL SURGICAL, UMBILICUPDeroyal·2002-06-13
• K810500 — BLOOD FREEZING BAGDelmed, Inc.·1981-09-23
• K810897 — ALPHA PLASTIC PLASMA BOTTLEAlpha Therapeutic Corp.·1981-09-23
• K811523 — PLASMA FLEXTerumo America, Inc.·1981-09-09
• K811449 — HAEMONETICS 1000ML COMPONENT BAGHaemonetics Corp.·1981-07-01
• K810711 — HAEMONETICS 600 ML. COMPONENT BAGHaemonetics Corp.·1981-05-08
• K810313 — HAEMONETICS 1400 ML THERAPEUTIC BAGHaemonetics Corp.·1981-03-31
• K801082 — GAMBRO HEMOFREEZE-BAGGambro, Inc.·1980-10-31
• K801219 — PLASMAPOOLERNorth American Biologicals, Inc.·1980-10-31
• K792395 — PHARMAFLEX CRYOGENIC BAGPharmachem Corp.·1980-02-26
• K792185 — PIASMA SAFECry-O-Safe, Inc.·1979-12-28
• K791673 — EMPTY TRANSFER BAGDelmed, Inc.·1979-10-23
• K781811 — TRANSFER PAK 4R 9006Travenol Laboratories, S.A.·1978-11-08
• K780354 — CRYOCYTE PACKTravenol Laboratories, S.A.·1978-06-14
• K760952 — TERASAKI LYMPHOCYTE TRANSPORT KITDravon Medical, Inc.·1977-01-17