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510(k) K190538

NIO-I by Waismed, Ltd. — Product Code FMI

K190538 is an FDA 510(k) premarket notification submitted by Waismed, Ltd. for the device "NIO-I". The FDA issued a decision of Substantially Equivalent on October 7, 2019. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Waismed, Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2019
Date Received
March 4, 2019
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 Waismed, Ltd.

  • K211968 — NIO+ Adult (July 22, 2021)
  • K160805 — NIO-P (June 23, 2016)
  • K142086 — NIO -INTRAOSSEOUS DEVICE (August 28, 2014)
  • K062940 — BONE INJECTION GUN (B.I.G.) (December 22, 2006)
  • K022415 — BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST (October 11, 2002)
  • K981853 — BONE INJECTION GUN (B.I.G.) DEVICE (November 17, 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