Home / 510(k) Clearances / K981548

510(k) K981548

NFC NEEDLEFREE CONNECTOR MODEL 69900 by Filtertek, Inc. — Product Code FPA

K981548 is an FDA 510(k) premarket notification submitted by Filtertek, Inc. for the device "NFC NEEDLEFREE CONNECTOR MODEL 69900". The FDA issued a decision of Substantially Equivalent on June 18, 1998. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Filtertek, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1998
Date Received
April 30, 1998
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 Filtertek, Inc.

  • K981547 — NFC NEEDLEFREE Y-SITE, MODEL 69970 (June 18, 1998)
  • K914792 — PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET (January 15, 1992)
  • K912848 — I.V. FILTER EXTENSION SET (November 29, 1991)
  • K912394 — TRANSDUCER PROTECTOR (August 30, 1991)
  • K911451 — I.V. EXTENDER SET (June 6, 1991)
  • K904912 — TRANSDUCER PROTECTOR (January 4, 1991)
  • K901409 — TRANSDUCER PROTECTOR (July 27, 1990)
  • K901996 — FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR (June 1, 1990)
  • K895281 — TRANSDUCER PROTECTOR (November 8, 1989)

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