Home / 510(k) Clearances / K821096

510(k) K821096

A-LINER by Martell Medical Products, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1982
Date Received
April 20, 1982
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)
  • K841810 — MARK5 ARTERIAL BLOOD GAS KIT (July 6, 1984)
  • K822786 — MDM ARTERIAL BLOOD GAS KIT (October 21, 1982)
  • K822760 — ARTERIAL LINE KIT (September 28, 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)