Kendall Curity Feeding Tubes
FDA 510(k) K892431 · The Kendal Co.
510(k) numberK892431
Submission
- Device name
- Kendall Curity Feeding Tubes
- Applicant
- The Kendal Co.
Boston, MA, US - Received
- April 10, 1989
- Decision date
- May 19, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K100700 | Med-Rx Pediatric Feeding Tubes and AccessoriesFPD · Traditional | Benlan, Inc. | 12/13/2010SE |
| K101214 | Guardian ConnectionFPD · Traditional | Maulin Medical, LLC | 07/23/2010SE |
| K100099 | Oral/Enteral SyringesFPD · Traditional | Philips Children'S Medical Ventures | 06/14/2010SE |
More from Philips Children'S Medical Ventures
| 510(k) | Device | Decision |
|---|---|---|
| K000087 | Marhukar Triple Lumen Catheter, Model 12 FRFOZ · Traditional | 03/17/2000SE |
| K990500 | Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter…EZL · Abbreviated | 09/28/1999SE |
| K991758 | Monoject Insulin SyringeFMF · Abbreviated | 06/14/1999SE |
| K970969 | Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement SetKOB · Traditional | 04/23/1997SE |
| K951488 | Kendall Curity Catheter Plug with Protective CapKNY · Traditional | 04/25/1995SE |
| K942664 | Kendall Model 6325 SCD Sequel Compression SystemJOW · Traditional | 01/17/1995SE |
| K942774 | Polyskin(R) M.R. Moist Responsive Transparent DressingMGP · Traditional | 07/20/1994SN |
| K892434 | Kendall Curity Oxygen MaskBYG · Traditional | 08/15/1989SE |
| K892440 | Kendall Curity Extension TubesFPA · Traditional | 07/24/1989SE |
| K892438 | Kendall Curity Intravascular Cut Down TubesFPA · Traditional | 07/24/1989SE |
Questions and answers
When was Kendall Curity Feeding Tubes cleared by the FDA?
Kendall Curity Feeding Tubes (K892431) received a 510(k) decision of Substantially Equivalent on May 19, 1989, 39 days after the submission was received.
What is the product code of K892431?
The FDA product code is FPD – Tube, Feeding, a Class II (moderate risk) device regulated under 21 CFR 876.5980.