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510(k) K243652

Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE) by Cardinalhealth — Product Code PNR

K243652 is an FDA 510(k) premarket notification submitted by Cardinalhealth for the device "Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE)". The FDA issued a decision of Substantially Equivalent on December 19, 2024. The device falls under product code PNR (Enteral Syringes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980. Cardinalhealth has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2024
Date Received
November 26, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.

Other clearances by Cardinalhealth

  • K252313 — Cardinal Health Nitrile Examination Gloves Extended Cuff (January 14, 2026)
  • K243660 — Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syri (August 22, 2025)
  • K230569 — Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Healt (July 3, 2023)
  • K213174 — Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection (May 19, 2022)
  • K202217 — Kendall NPWT Incision Management Device (June 4, 2021)
  • K191101 — Kendall NPWT Incision Management Dressing Kit (July 31, 2020)
  • K190923 — Salem Sump Dual Lumen Stomach Tube with ENFit Connection (November 7, 2019)
  • K171499 — Occlusion Detection Dressing Kit (September 22, 2017)
  • K161418 — Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Deli (January 19, 2017)
  • K150769 — Cardinal Health Trochanteric IM Nail System (December 14, 2015)

Other clearances for product code PNR

  • K252483 — Enteral Syringe (20ml, 60ml) (July 1, 2026)
  • K253268 — Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding (April 8, 2026)
  • K251585 — Profoject™ Enteral Feeding Syringe (July 18, 2025)
  • K231300 — Nutricair Enteral Syringe with ENFit (October 6, 2023)
  • K222772 — Oral/Enteral Syringe with ENFit connector (August 17, 2023)
  • K211661 — ENFit enteral syringes (NUTRIFIT) (February 28, 2022)
  • K211593 — Enteral Pump Syringe (September 30, 2021)
  • K203613 — ENFit Reusable Enteral Syringe (August 27, 2021)
  • K211025 — Oral/Enteral Syringe with ENFit connector (June 30, 2021)
  • K203410 — ENFit Disposable Enteral Syringe (June 28, 2021)

FDA data resources