DeviceClearance

Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) +2 more— 510(k) K253514

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K253514 for Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) +2 more, Substantially Equivalent on 2026-07-10. Applicant: C.R. Bard, Inc.. Device class: 2.

Summary

C.R. Bard's clearance covers three tubes: the Minnesota Four-Lumen Esophagogastric Tamponade Tube in 18 French (0092220) and the Blakemore Esophageal-Nasogastric Tube in 20 French (0092100) and 16 French (0092300). They're filed under KNT, gastrointestinal tubes and accessories.

Class II, 21 CFR 876.5980. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).

Bard filed from Covington, Georgia. Review took 246 calendar days (November 6, 2025 to July 10, 2026).

Clearance details

Device name as filed
Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)
Applicant
C.R. Bard, Inc.
Product code
Product code KNT
Device class
Class 2
Regulation
21 CFR 876.5980
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Covington, GA, US
Download summary PDFView on FDA.gov ↗

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More clearances from C.R. Bard, Inc.

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Adverse events under product code KNT

product code KNT
Death
192
Injury
6,034
Malfunction
4,049
Other
1
Total
10,276

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.