Cleared Traditional

K921853 - 4 SURE TM FEEDING TUBES

K921853 is an FDA 510(k) clearance for 4 SURE TM FEEDING TUBES, manufactured by Boston Pacific Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 452-day FDA review.

K921853 · Boston Pacific Medical, Inc. · Gastroenterology & Urology device
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Jul 1993
Decision
452d
Days
Class 2
Risk

K921853 is an FDA 510(k) clearance for the 4 SURE TM FEEDING TUBES. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Boston Pacific Medical, Inc. (Boston, US). The FDA issued a Cleared decision on July 13, 1993 after a review of 452 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 Boston Pacific Medical, Inc. devices

FDA 510(k) Submission Details - K921853

510(k) Number K921853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1992
Decision Date July 13, 1993
Days to Decision 452 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
321d slower than avg
Panel avg: 131d · This submission: 452d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 500
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K921853.
FLEXIFLO 60 NASOJEJUNAL FEEDING TUBE
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FLEXIFLO LAPAROSCOPIC GASTROSTOMY KIT
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GASTROPORT II
K924308 · Sandoz Nutrition · Jul 1993
BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC
K915841 · C.R. Bard, Inc. · Jun 1993
STOMA MEASURING DEVICE
K923692 · Applied Medical Technologies · May 1993
PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT
K923983 · Sandoz Nutrition · Apr 1993