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510(k) K150034

AMT Enteral Transition Adapters by Applied Medical Technology, Inc. — Product Code PIO

K150034 is an FDA 510(k) premarket notification submitted by Applied Medical Technology, Inc. for the device "AMT Enteral Transition Adapters". The FDA issued a decision of Substantially Equivalent on June 9, 2015. The device falls under product code PIO (Enteral Specific Transition Connectors), a Class II device regulated under 21 CFR 876.5980. Applied Medical Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2015
Date Received
January 9, 2015
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 Applied Medical Technology, Inc.

  • K252438 — Explant Express (February 3, 2026)
  • K240514 — AMT Low-Profile Suprapubic Catheter & Drainage Set (November 1, 2024)
  • K241111 — AMT Suture Passer (July 5, 2024)
  • K222846 — AMT G-Tube Balloon Gastrostomy Feeding Device (December 18, 2023)
  • K202539 — Nutriglide(TM) Nasal Feeding Tube (October 29, 2020)
  • K193612 — AMT Suture Delivery System (March 12, 2020)
  • K183508 — Micro Transgastric-Jejunal Feeding Device (March 29, 2019)
  • K182804 — Traditional Length GJ Feeding Device (March 1, 2019)
  • K180026 — Bowel Management Device, Bowel Management Irrigation Set (June 1, 2018)
  • K170319 — Low Profile Non-Balloon Feeding Device (October 6, 2017)

Other clearances for product code PIO

  • K231299 — Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector (January 22, 2024)
  • 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)
  • 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