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510(k) K982541

VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 by Becton Dickinson Vacutainer Systems — Product Code FMI

K982541 is an FDA 510(k) premarket notification submitted by Becton Dickinson Vacutainer Systems for the device "VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608". The FDA issued a decision of Substantially Equivalent on October 28, 1998. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Becton Dickinson Vacutainer Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1998
Date Received
July 21, 1998
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 Becton Dickinson Vacutainer Systems

  • K002456 — MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 (November 2, 2000)
  • K991702 — MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, (July 28, 1999)
  • K991088 — VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY- (May 28, 1999)
  • K991120 — VACUTAINER BRAND CTAD TUBE (MULTIPLE) (May 19, 1999)
  • K982922 — VACUTAINER BRAND BLOOD COLLECTION SYRINGE (September 22, 1998)
  • K981013 — VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE (June 17, 1998)
  • K972075 — VACUTAINER BRAND PPT PLASMA PREPARATION TUBE (February 24, 1998)
  • K980098 — VACUTAINER BRAND PRONTO NEEDLES HOLDER (February 5, 1998)
  • K971449 — VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) (June 17, 1997)
  • K960250 — VACUTAINER BRAND PLUS SERUM & SST TUBES (March 29, 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