Home / 510(k) Clearances / K841810

510(k) K841810

MARK5 ARTERIAL BLOOD GAS KIT by Martell Medical Products, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1984
Date Received
May 1, 1984
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 Martell Medical Products, Inc.

  • K945454 — LEUR TIP CAP, VLT CAP(TM) (April 14, 1995)
  • K944941 — PISTON SYRINGE (December 5, 1994)
  • K822786 — MDM ARTERIAL BLOOD GAS KIT (October 21, 1982)
  • K822760 — ARTERIAL LINE KIT (September 28, 1982)
  • K821096 — A-LINER (May 14, 1982)
  • K812560 — MDM ARTERIAL BLOOD GAS SYRINGE (October 9, 1981)

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)