Cleared Traditional

K930510 - RADIUS ENTERAL FEEDING TUBE

K930510 is an FDA 510(k) clearance for RADIUS ENTERAL FEEDING TUBE, manufactured by Radius Intl., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code BSS cleared through the Traditional 510(k) pathway after a 730-day FDA review.

K930510 · Radius Intl., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
730d
Days
Class 2
Risk

K930510 is an FDA 510(k) clearance for the RADIUS ENTERAL FEEDING TUBE. Classified as Tube, Nasogastric (product code BSS), Class II - Special Controls.

Submitted by Radius Intl., Inc. (Grayslake, US). The FDA issued a Cleared decision on February 1, 1995 after a review of 730 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Radius Intl., Inc. devices

FDA 510(k) Submission Details - K930510

510(k) Number K930510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1993
Decision Date February 01, 1995
Days to Decision 730 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
600d slower than avg
Panel avg: 130d · This submission: 730d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSS Device Classification - Class 2, Special Controls

Product Code BSS Tube, Nasogastric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - BSS Tube, Nasogastric

Devices cleared under the same product code (BSS) and FDA review panel - the closest regulatory comparables to K930510.
ENTERAL FEEDING TUBE
K051480 · Biosearch Medical Products, Inc. · Oct 2005
ASPISAFE GASTRIC TUBE
K961711 · B.Braun Medical, Inc. · Jun 1997
ARGYLE POLYURETHANE SALEM SUMP TUBE
K910479 · Sherwood Medical Co. · Apr 1991
TECNOL NASO-GASTRIC TUBE HOLDER
K891187 · Tecnol New Jersey Wound Care, Inc. · May 1989
FLEXIFLO ENTERAL PUMP SET
K791531 · Abbott Laboratories · Sep 1979