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510(k) K791462

HYPERDERMIC NEEDLE WITH SENSOR #514 by Medtech Intl., Inc. — Product Code FMI

K791462 is an FDA 510(k) premarket notification submitted by Medtech Intl., Inc. for the device "HYPERDERMIC NEEDLE WITH SENSOR #514". The FDA issued a decision of Substantially Equivalent on September 24, 1979. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Medtech Intl., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1979
Date Received
July 16, 1979
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 Medtech Intl., Inc.

  • K920876 — CUT RESISTANT GLOVES OR SURGICAL GLOVE LINER (December 11, 1992)
  • K853843 — IV MATE (January 9, 1986)
  • K790389 — GAUZE & COTTON SPONGES (March 26, 1979)
  • K790467 — SURGICAL EYE SPONGE (March 26, 1979)
  • K781157 — STIMULATOR, NERVE, TRANSCUTANEOUS (September 20, 1978)

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