Enteral Specific Transition Connectors
Enteral Specific Transition Connectors are medical devices that facilitate connections between AAMI/CN3(PS):2014 compliant connectors and non-ISO 80369-1 compliant legacy enteral connectors, enabling safe enteral feeding during the transition to standardized connector systems. They are FDA Class 2 devices regulated under 21 CFR 876.5980, requiring 510(k) premarket notification, within the Gastroenterology and Urology (GU) specialty. The product code is PIO. These devices are not implants and are not life-sustaining.
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Basic Information
- Product Code
- PIO
- Device Class
- FDA class 2
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K231299 | Nutricair enteral ENFit adapter: ENFit male stepped/Christmas tree connector | Jan 22, 2024 | Substantially Equivalent | Cair Lgl |
| K233190 | ENFit Adaptor | Jan 18, 2024 | Substantially Equivalent | Jiangsu Caina Medical Co.,Ltd |
| K220165 | Enteral Transition Adaptor | Oct 21, 2022 | Substantially Equivalent | GBUK Group, Ltd. |
| K162254 | Cedic Enteral ENFit Transition Connectors | May 04, 2017 | Substantially Equivalent | Cedic S.R.L. |
| K151237 | Nutrisafe 2- ENFit Adaptor | Feb 09, 2016 | Substantially Equivalent | Vygon |
| K151628 | Medline ENFit Connectors | Jul 24, 2015 | Substantially Equivalent | Medline Industries, Inc. |
| K150034 | AMT Enteral Transition Adapters | Jun 09, 2015 | Substantially Equivalent | Applied Medical Technology, Inc. |
| K150010 | Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port | Apr 02, 2015 | Substantially Equivalent | Cedic S.R.L. |
| K140581 | CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT | Oct 17, 2014 | Substantially Equivalent | Cedic S.R.L. |
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.