Med-Rx Pediatric Feeding Tubes and Accessories
FDA 510(k) K100700 · Benlan, Inc.
510(k) numberK100700
Submission
- Device name
- Med-Rx Pediatric Feeding Tubes and Accessories
- Applicant
- Benlan, Inc.
Oakville, CA - Received
- March 12, 2010
- Decision date
- December 13, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPD – Tube, Feeding
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FPD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243361 | NutrifitFPD · Traditional | Vygon USA | 12/19/2024SE |
| K180236 | VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)FPD · Traditional | Vr Medical Technology Co., Ltd. | 01/18/2019SE |
| K131590 | Innersense Esophageal Temperature Probe / Feeding TubeFPD · Traditional | Philips Medical Systems | 10/23/2013SE |
| K120815 | Innersense Esophageal Temperature/Feeding TubeFPD · Traditional | Philips Medical Systems | 03/06/2013SE |
| K121105 | Nutrisafe 2 Feeding TubeFPD · Traditional | Vygon Corp. | 12/18/2012SE |
| K100163 | Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXXFPD · Traditional | Vygon Corp. | 10/13/2011SE |
| K110853 | VR Medical Enteral Oral SyringeFPD · Traditional | Vr Medical | 05/13/2011SE |
| K101214 | Guardian ConnectionFPD · Traditional | Maulin Medical, LLC | 07/23/2010SE |
| K100099 | Oral/Enteral SyringesFPD · Traditional | Philips Children'S Medical Ventures | 06/14/2010SE |
| K100526 | Ameritus Entral (TM) Enteral Feeding TubeFPD · Traditional | Kentec Medical, Inc. | 04/22/2010SE |
More from Kentec Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K131183 | Med-Rx Oral/Enteral SyringeKNT · Traditional | 06/03/2014SE |
| K120375 | Med-Rx Patient Delivery SetFPA · Traditional | 06/28/2012SE |
| K112799 | Med-Rx Extension Set with T-ConnectorFPA · Traditional | 12/23/2011SE |
| K102073 | Med-Rx Transfer Set, Models 10-1227TS, 10-1300TS, 10-1305TS and 10-1306TSFPA · Traditional | 11/08/2010SE |
| K010607 | Med-Rx Irrigation Set, Model 10-3001, 10-3002, 10-4000, 10-4001LJH · Traditional | 11/28/2001SE |
| K990777 | Med-Rx Extension SetsFPA · Traditional | 08/25/1999SE |
Questions and answers
When was Med-Rx Pediatric Feeding Tubes and Accessories cleared by the FDA?
Med-Rx Pediatric Feeding Tubes and Accessories (K100700) received a 510(k) decision of Substantially Equivalent on December 13, 2010, 276 days after the submission was received.
What is the product code of K100700?
The FDA product code is FPD – Tube, Feeding, a Class II (moderate risk) device regulated under 21 CFR 876.5980.