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510(k) K823696

MICRO Z BLOOD COLLECTING NEEDLES by Hospital Products Co. — Product Code FMI

K823696 is an FDA 510(k) premarket notification submitted by Hospital Products Co. for the device "MICRO Z BLOOD COLLECTING NEEDLES". The FDA issued a decision of Substantially Equivalent on January 26, 1983. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Hospital Products Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1983
Date Received
December 8, 1982
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 Hospital Products Co.

  • K810318 — PARKE-DAVIS NON-WOVEN SPONGE (February 26, 1981)
  • K801602 — DESERET I.V. FILTER (August 27, 1980)
  • K801173 — ANGIO-FLO MONITORING KIT (May 28, 1980)
  • K792386 — NUTRA-PH INSTRUMENT MILK (December 10, 1979)
  • K791350 — POPE AMBULATORY HALO VEST (August 3, 1979)

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