Home / 510(k) Clearances / K231095

510(k) K231095

Tamper Evident Cap by International Medical Industries, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2024
Date Received
April 18, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by International Medical Industries, Inc.

  • K201031 — NRFit® Caps, Male and Female Neuraxial Tip Caps (December 16, 2020)
  • K193192 — Tamper Evident Cap (January 31, 2020)
  • K190305 — Additive Cap (April 30, 2019)
  • K182545 — Tamper Evident Cap with Male Luer Lock (January 11, 2019)
  • K173577 — Guarded Luer Connector (June 7, 2018)
  • K170672 — Tamper Evident Cap For use with ENFit Syringes (October 6, 2017)

Other clearances for product code FMF

  • K253068 — Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (February 23, 2026)
  • K253769 — Instylla Delivery Kit (December 22, 2025)
  • K252518 — DuoprossTM Smart Cap (Type I) (December 17, 2025)
  • K251089 — EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Sy (December 12, 2025)
  • K250192 — Verisafe Safety Retractable Insulin Syringes (December 10, 2025)
  • K250853 — Merit Syringe (November 4, 2025)
  • K250510 — Sure-Fine Insulin Syringes (October 15, 2025)
  • K243660 — Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syri (August 22, 2025)
  • K251350 — BD Plastipak™ Syringe (July 29, 2025)
  • K252033 — Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle (July 25, 2025)