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510(k) K231299

Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector by Cair Lgl — Product Code PIO

K231299 is an FDA 510(k) premarket notification submitted by Cair Lgl for the device "Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector". The FDA issued a decision of Substantially Equivalent on January 22, 2024. The device falls under product code PIO (Enteral Specific Transition Connectors), a Class II device regulated under 21 CFR 876.5980. Cair Lgl has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2024
Date Received
May 4, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enteral Specific Transition Connectors
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.

Other clearances by Cair Lgl

  • K231300 — Nutricair Enteral Syringe with ENFit (October 6, 2023)
  • K213258 — Nasogastric Feeding Tubes - ENFit Port - PVC (June 9, 2022)
  • K210598 — Pediatric Nasogastric Feeding Tubes - Single ENFit Port (November 2, 2021)
  • K171117 — Carefusion NeutraClear Needle-free connector (EL-NC1000) (September 1, 2017)
  • K171118 — Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) (August 15, 2017)
  • K171132 — Carefusion NeutraClear Needle-free connector (July 31, 2017)
  • K133073 — CAIR DRIVE, NEUTRACLEAR (March 20, 2014)

Other clearances for product code PIO

  • K233190 — ENFit Adaptor (January 18, 2024)
  • K220165 — Enteral Transition Adaptor (October 21, 2022)
  • K162254 — Cedic Enteral ENFit Transition Connectors (May 4, 2017)
  • K151237 — Nutrisafe 2- ENFit Adaptor (February 9, 2016)
  • K151628 — Medline ENFit Connectors (July 24, 2015)
  • K150034 — AMT Enteral Transition Adapters (June 9, 2015)
  • K150010 — Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port (April 2, 2015)
  • K140581 — CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSIT (October 17, 2014)

FDA data resources