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510(k) K973012

MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM by MDC Research , Ltd. — Product Code FMI

K973012 is an FDA 510(k) premarket notification submitted by MDC Research , Ltd. for the device "MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM". The FDA issued a decision of Substantially Equivalent on November 5, 1997. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. MDC Research , Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1997
Date Received
August 13, 1997
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 MDC Research , Ltd.

  • K022959 — SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1 (February 5, 2003)
  • K960013 — MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM (February 13, 1996)

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