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510(k) K211593

Enteral Pump Syringe by Jiangsu Caina Medical Co.,Ltd — Product Code PNR

K211593 is an FDA 510(k) premarket notification submitted by Jiangsu Caina Medical Co.,Ltd for the device "Enteral Pump Syringe". The FDA issued a decision of Substantially Equivalent on September 30, 2021. The device falls under product code PNR (Enteral Syringes With Enteral Specific 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
September 30, 2021
Date Received
May 24, 2021
Clearance Type
Traditional
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 Jiangsu Caina Medical Co.,Ltd

  • K232781 — Safety Sliding Blood Collection Set (March 7, 2024)
  • K233190 — ENFit Adaptor (January 18, 2024)
  • K230635 — Pen Needle (June 2, 2023)
  • K220184 — Pump Alignment Syringe (July 21, 2022)
  • 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 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)
  • K243652 — Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syring (December 19, 2024)
  • 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)
  • 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