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510(k) K942271

LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE by Level 1 Technologies, Inc. — Product Code FPA

K942271 is an FDA 510(k) premarket notification submitted by Level 1 Technologies, Inc. for the device "LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE". The FDA issued a decision of Substantially Equivalent on July 12, 1995. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Level 1 Technologies, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1995
Date Received
May 10, 1994
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 Level 1 Technologies, Inc.

  • K942844 — LEVEL 1 BLOOD STREAM RECOVERY SYSTEM (April 26, 1996)
  • K936223 — PRESSURE IRRIGATING SYSTEM (May 12, 1994)
  • K911383 — HOTLINE FLUID WARMER (October 17, 1991)
  • K873435 — LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET (October 5, 1987)

Other clearances for product code FPA

  • K254123 — Ecomed Disposable Administration Sets (September 11, 2026)
  • 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)

FDA data resources