Enteral Pump Set W/Entera-Flo Spike
FDA 510(k) K895650 · Delmed, Inc.
510(k) numberK895650
Submission
- Device name
- Enteral Pump Set W/Entera-Flo Spike
- Applicant
- Delmed, Inc.
New Brunswick, NJ, US - Received
- September 20, 1989
- Decision date
- October 2, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNT – Tubes, Gastrointestinal (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KNT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261890 | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®KNT · Special | Boehringer Laboratories, LLC | 08/14/2026SE |
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | C.R. Bard, Inc. | 07/10/2026SE |
| K250389 | XNY Disposable Gastric Calibration TubeKNT · Traditional | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 04/10/2025SE |
| K243228 | Flexi-Seal AIR (with ENFit Connector)KNT · Traditional | Convatec | 03/28/2025SE |
| K242336 | hygh-tec Drainage IIKNT · Traditional | Amb Medtec | 01/17/2025SE |
| K242901 | ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT…KNT · Traditional | Tools For Surgery, LLC | 01/10/2025SE |
| K241169 | Entarik NI Feeding Tube SystemKNT · Traditional | Gravitas Medical, Inc. | 11/22/2024SE |
| K241185 | CORGRIP* SR NG/NI Tube Retention SystemKNT · Traditional | Avanos Medical, Inc. | 10/25/2024SE |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950)KNT · Traditional | Avanos Medical, Inc. | 06/06/2024SE |
| K233591 | StylusKNT · Traditional | Degania Silicone , Ltd. | 05/31/2024SE |
More from Degania Silicone , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K895329 | 600ML and 1200ML Enteral Bag Adm. Set for EnteraKNT · Traditional | 10/02/1990SE |
| K895142 | Enteral Pump Set with Enteral SpikeKNT · Traditional | 10/02/1990SE |
| K894506 | Entera-Flo Enteral Feeding PumpFRN · Traditional | 08/06/1990SE |
| K901478 | Delmed 80/2 Dialysis System W/Last Bag OptionFKX · Traditional | 07/27/1990SE |
| K901477 | Delmed 80/2 Dialysis System W/UltrafiltrationFKX · Traditional | 07/27/1990SE |
| K900106 | Closed Disconnect SystemKDJ · Traditional | 07/16/1990SE |
| K895933 | Enteral Pump Sets for Use with Ross Flexiflo-IiiKNT · Traditional | 05/02/1990SE |
| K895919 | Enteral Bag Admini. Sets for Use W/Flexiflo-IiiKNT · Traditional | 05/02/1990SE |
| K895696 | Enteral Pump Set W/Enteral Spike for Use W/Feed PuKNT · Traditional | 05/02/1990SE |
| K895330 | 600ML and 1200ML Enteral Bag Adm. Set for FrentaKNT · Traditional | 05/02/1990SE |
Questions and answers
When was Enteral Pump Set W/Entera-Flo Spike cleared by the FDA?
Enteral Pump Set W/Entera-Flo Spike (K895650) received a 510(k) decision of Substantially Equivalent on October 2, 1990, 377 days after the submission was received.
What is the product code of K895650?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.