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510(k) K233190

ENFit Adaptor by Jiangsu Caina Medical Co.,Ltd — Product Code PIO

K233190 is an FDA 510(k) premarket notification submitted by Jiangsu Caina Medical Co.,Ltd for the device "ENFit Adaptor". The FDA issued a decision of Substantially Equivalent on January 18, 2024. The device falls under product code PIO (Enteral Specific Transition Connectors), a Class II device regulated under 21 CFR 876.5980. Jiangsu Caina Medical Co.,Ltd has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2024
Date Received
September 28, 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 Jiangsu Caina Medical Co.,Ltd

  • K232781 — Safety Sliding Blood Collection Set (March 7, 2024)
  • K230635 — Pen Needle (June 2, 2023)
  • K220184 — Pump Alignment Syringe (July 21, 2022)
  • K211593 — Enteral Pump Syringe (September 30, 2021)
  • K210217 — Needleless Connector (May 17, 2021)
  • K200463 — Huber Needle Infusion Set, Safety Huber Needle Infusion Set (April 7, 2021)
  • K201356 — Plastic LOR Syringe (February 12, 2021)
  • K200027 — Blood Collection Needle with/without Holder, Safety Blood Collection Needle with (September 9, 2020)
  • K193022 — Retractable Safety Insulin Syringe (July 20, 2020)
  • K193526 — Syringe with safety needle, Safety needle (July 17, 2020)

Other clearances for product code PIO

  • K231299 — Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector (January 22, 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