Home / 510(k) Clearances / K961327

510(k) K961327

BEC NEEDLELESS INJECTION SITE by Biological & Environmental Control Laboratories — Product Code FPA

K961327 is an FDA 510(k) premarket notification submitted by Biological & Environmental Control Laboratories for the device "BEC NEEDLELESS INJECTION SITE". The FDA issued a decision of Substantially Equivalent on May 15, 1996. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Biological & Environmental Control Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1996
Date Received
April 8, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Biological & Environmental Control Laboratories

  • K971500 — ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER (August 18, 1997)
  • K962801 — SAFE MATE I.V. EXTENSION SETS (August 28, 1996)
  • K962802 — SAFE MATE I.V. FLUID DELIVERY SETS (August 28, 1996)
  • K961328 — BEC SHROUDED PLASTIC CANNULA (May 30, 1996)
  • K863635 — UPDATED STERILE ENDOTRACHEAL BRUSHES (November 3, 1986)
  • K863633 — SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES (October 16, 1986)
  • K863636 — UPDATED STERILE GENERAL HOSPITAL INSTRUMENTS (October 6, 1986)
  • K863632 — UPDATED STERILE PROCEDURAL KIT (September 29, 1986)
  • K863637 — UPDATED STERILE GOWNS, MASKS AND TOWELS (September 29, 1986)
  • K851851 — STERILE ENDOTRACHEAL BRUSHES (June 5, 1985)

Other clearances for product code FPA

  • K261530 — iiSure Infusion Set (June 3, 2026)
  • K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, (May 4, 2026)
  • K251375 — PuraCath Firefly Needleless Connector IT (9005) (February 12, 2026)
  • K251257 — nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Fre (December 4, 2025)
  • K250325 — BD Alaris Pump Infusion Set (October 30, 2025)
  • K251814 — EZ™ IV Administration Set (August 29, 2025)
  • K251854 — SteadiSet infusion set (August 6, 2025)
  • K243841 — Sparta Infusion Set for Insulin (August 1, 2025)
  • K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets (July 24, 2025)
  • K250616 — Clave™ Neutral-Displacement Needlefree Connectors (June 5, 2025)

FDA data resources