Nasogastric Tube Holder, Model 160
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K994300 FDA 510(k)
- FDA Product Code
- KNT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5980 FDA 510(k)
- Regulation Number
- 876.5980 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nasogastric Tube Holder, Model 160, is a medical device designed to secure and stabilize nasogastric tubes in place. It is classified under the product code KNT and is intended for use in clinical settings where nasogastric tube management is required, such as in gastroenterology and urology procedures.
This device is supplied as a reusable medical accessory and has received FDA 510(k) clearance under the Traditional pathway, demonstrating substantial equivalence to a predicate device. It is intended for use in sterile or semi-sterile environments, adhering to standard medical practice guidelines for tube management. The holder is regulated under the MDR framework and is distributed by Dale Medical Products, Inc., based in Plainville, Massachusetts.
Frequently asked questions
Is the Nasogastric Tube Holder, Model 160, intended for single-use or can it be reused in clinical settings?
The Nasogastric Tube Holder, Model 160, is explicitly designed as a reusable medical accessory. While it is intended for use in sterile or semi-sterile environments, it is not labeled as single-use. Proper cleaning and sterilization procedures must follow standard medical practice guidelines to ensure safe reuse.
What clinical specialties or procedures is this device primarily associated with, based on its regulatory submission?
The device was reviewed under the Gastroenterology and Urology advisory committees, indicating its primary association with procedures involving nasogastric tube management in those specialties. This does not imply an indication but reflects the context in which it was evaluated for substantial equivalence.
How is the Nasogastric Tube Holder, Model 160, distributed, and who is the manufacturer?
The device is manufactured by Dale Medical Products, Inc. and distributed from their headquarters at 7 Cross St., P.O. Box 1556, Plainville, MA 02762. The company is based in the United States and handles both domestic and international distribution.
What regulatory pathways were followed for clearance of this device, and when was the decision made?
The Nasogastric Tube Holder, Model 160, received FDA 510(k) clearance under the Traditional pathway, demonstrating substantial equivalence to a predicate device. The decision was made on February 10, 2000, following review by the Gastroenterology/Urology (GU) advisory committee. It is also regulated under the MDR framework as part of its compliance requirements.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K994300 | Class II | Active |
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Manufacturer
- Manufacturer
- Dale Medical Products, Inc.
Sources (2)
- FDA 510(k) K994300 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026