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510(k) K861152

EXEL VACUUM BLOOD COLLECTING SYSTEM by Exel Intl. — Product Code FMI

K861152 is an FDA 510(k) premarket notification submitted by Exel Intl. for the device "EXEL VACUUM BLOOD COLLECTING SYSTEM". The FDA issued a decision of Substantially Equivalent on May 6, 1986. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Exel Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1986
Date Received
March 26, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Exel Intl.

  • K992290 — EXEL INJECTION PLUG WITH CAP (February 23, 2000)
  • K963658 — EXEL AVF SINGLE NEEDLE (May 5, 1998)
  • K963659 — EXEL I.V. ADMINISTRATION SET (December 16, 1997)
  • K926119 — EXEL HUBER INFUSION SET ROTATING WING (August 11, 1993)
  • K904685 — EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y) (November 21, 1990)
  • K903945 — EXEL A-V FISTULA SET (November 20, 1990)
  • K895770 — EXEL HUBER INFUSION SET (July 19, 1990)
  • K895771 — EXEL SPINAL NEEDLES (February 16, 1990)
  • K895768 — EXEL SAFELET CATHETER (February 16, 1990)
  • K895772 — EXEL INDWELLING CATHETER (February 16, 1990)

Other clearances for product code FMI

  • K261266 — MOWANA™ Auto Duo (September 17, 2026)
  • K261719 — Promisemed X-Safety Pen Needle (August 25, 2026)
  • K262427 — Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, (August 10, 2026)
  • K260933 — Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, N (August 7, 2026)
  • K261829 — Profoject™ Dual-Safety Pen Needles (July 29, 2026)
  • K260739 — Profoject™ Pen Needles (Model A; Model B) (July 15, 2026)
  • K260855 — Profoject™ Safety Pen Needles (June 10, 2026)
  • K254273 — Verisafe Safety Sterile Needles (SSN) (April 16, 2026)
  • K252908 — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen (March 25, 2026)
  • K253047 — PRESSONE™ (March 24, 2026)

FDA data resources