ONAT Ballooned Nasogastric Tube

by Macdonald Medical Devices, Inc.

510(k) K920262

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K920262↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK920262	Date20 Apr 1993Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K920262
FDA Product Code: KNT

Device Class: Class II
Regulation: 21 CFR Part 876.5980
Advisory Committee: Gastroenterology, Urology
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ONAT Ballooned Nasogastric Tube is a nasogastric tube with an inflatable balloon (Product Code: KNT), classified under the Gastroenterology and Urology categories. It is designed for gastric decompression, feeding, medication administration, and bowel irrigation by passing through the nasal passage into the stomach.

This device is intended for single-use and is supplied sterile. It is regulated under FDA 510(k) clearance (K920262) and is manufactured by Macdonald Medical Devices, Inc. No MRI safety information or reusable specifications are provided in the data.