FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Mini ONE Enteral Extension Set
K Number: K142989
·
Decision Jan 29, 2015
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
49
Applicant Total
25
Review Days
105
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Mini ONE Enteral Extension Set
- K Number
- K142989
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Applied Medical Technology, Inc.
- Date Received
- October 16, 2014
- Decision Date
- January 29, 2015
- Product Code
- PIF
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PIF), ordered by most recent decision date.
Percutaneous Endoscopic Gastrostomy (PEG) Kit
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Enteral Drainage System, Enteral Medicine straw
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Extension Feeding Set with ENFit Connectors
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Enteral Feeding Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Mobility+ Enteral Feeding System OTC
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENFit to ENFit Extension Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Applied Medical Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252438 | Explant Express | Feb 3, 2026 | Substantially Equivalent |
| K240514 | AMT Low-Profile Suprapubic Catheter & Drainage Set | Nov 1, 2024 | Substantially Equivalent |
| K241111 | AMT Suture Passer | Jul 5, 2024 | Substantially Equivalent |
| K222846 | AMT G-Tube Balloon Gastrostomy Feeding Device | Dec 18, 2023 | Substantially Equivalent |
| K202539 | Nutriglide(TM) Nasal Feeding Tube | Oct 29, 2020 | Substantially Equivalent |
| K193612 | AMT Suture Delivery System | Mar 12, 2020 | Substantially Equivalent |
| K183508 | Micro Transgastric-Jejunal Feeding Device | Mar 29, 2019 | Unknown |
| K182804 | Traditional Length GJ Feeding Device | Mar 1, 2019 | Substantially Equivalent |
| K180026 | Bowel Management Device, Bowel Management Irrigation Set | Jun 1, 2018 | Unknown |
| K170319 | Low Profile Non-Balloon Feeding Device | Oct 6, 2017 | Substantially Equivalent |