FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES
K Number: K100700
·
Decision Dec 13, 2010
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
58
Applicant Total
7
Review Days
276
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
- MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES
- K Number
- K100700
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Benlan, Inc.
- Date Received
- March 12, 2010
- Decision Date
- December 13, 2010
- Product Code
- FPD
- 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 |
|---|---|---|---|
| FPD | Tube, Feeding | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPD), ordered by most recent decision date.
Nutrifit
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NUTRISAFE 2 FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Benlan, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K131183 | MED-RX ORAL/ENTERAL SYRINGE | Jun 3, 2014 | Substantially Equivalent |
| K120375 | MED-RX PATIENT DELIVERY SET | Jun 28, 2012 | Substantially Equivalent |
| K112799 | MED-RX EXTENSION SET WITH T-CONNECTOR | Dec 23, 2011 | Substantially Equivalent |
| K102073 | MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS | Nov 8, 2010 | Substantially Equivalent |
| K010607 | MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 | Nov 28, 2001 | Substantially Equivalent |
| K990777 | MED-RX EXTENSION SETS | Aug 25, 1999 | Substantially Equivalent |