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510(k) K191258

Intraosseous infusion device by Einstein Works, LLC — Product Code FMI

K191258 is an FDA 510(k) premarket notification submitted by Einstein Works, LLC for the device "Intraosseous infusion device". The FDA issued a decision of Substantially Equivalent on Oct 23, 2019. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Einstein Works, LLC has 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 23, 2019
Date Received
May 10, 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
510(k)

Other clearances by Einstein Works, LLC

  • K211395 — NIO-I (Jul 28, 2021)
  • K182770 — Adult Intraosseous Infusion Device (Apr 9, 2019)

Other clearances for product code FMI

  • K261266 — MOWANA™ Auto Duo (Sep 17, 2026)
  • K261719 — Promisemed X-Safety Pen Needle (Aug 25, 2026)
  • K262427 — Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA… (Aug 10, 2026)
  • K260933 — Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R… (Aug 7, 2026)
  • K261829 — Profoject™ Dual-Safety Pen Needles (Jul 29, 2026)
  • K260739 — Profoject™ Pen Needles (Model A; Model B) (Jul 15, 2026)
  • K260855 — Profoject™ Safety Pen Needles (Jun 10, 2026)
  • K254273 — Verisafe Safety Sterile Needles (SSN) (Apr 16, 2026)
  • K252908 — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen… (Mar 25, 2026)
  • K253047 — PRESSONE™ (Mar 24, 2026)

FDA data resources