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510(k) K211968

NIO+ Adult by Waismed, Ltd. — Product Code FMI

K211968 is an FDA 510(k) premarket notification submitted by Waismed, Ltd. for the device "NIO+ Adult". The FDA issued a decision of Substantially Equivalent on July 22, 2021. 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
July 22, 2021
Date Received
June 24, 2021
Clearance Type
Special
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.

  • K190538 — NIO-I (October 7, 2019)
  • 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

  • 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)
  • K253622 — Safety Pen Needle (March 18, 2026)
  • K252886 — Pen Needle (January 6, 2026)
  • K250700 — Pen Injector Needle 32.5 (November 21, 2025)
  • K252631 — Profoject™ Disposable Needle (October 16, 2025)
  • K250724 — Intraosseous Infusion Needles (July 30, 2025)

FDA data resources