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510(k) K991904

MODIFICATION OF JMS NEEDLES AND JMS SYRINGES by Jms Co., Ltd. — Product Code FMI

K991904 is an FDA 510(k) premarket notification submitted by Jms Co., Ltd. for the device "MODIFICATION OF JMS NEEDLES AND JMS SYRINGES". The FDA issued a decision of Substantially Equivalent on August 31, 1999. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Jms Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1999
Date Received
June 4, 1999
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 Jms Co., Ltd.

  • K002352 — JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE (September 6, 2001)
  • K002394 — JMS APHERESIS NEEDLE SET ACCORDION TYPE (September 5, 2001)
  • K010410 — JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G (June 20, 2001)
  • K010406 — JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G (June 20, 2001)
  • K000845 — MODIFICATION TO JMS A.V. FISTULA NEEDLE SET (April 10, 2000)
  • K000843 — MODIFICATION TO JMS APHERESIS NEEDLE (April 10, 2000)
  • K990510 — JMS APHERESIS NEEDLE (August 30, 1999)
  • K990470 — JMS A. V. FISTULA NEEDLE SET (August 30, 1999)
  • K983707 — JMS DIALYZER PRIMING SET (January 8, 1999)
  • K974902 — JMS APHERESIS NEEDLE (March 30, 1998)

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