Cleared Traditional

K890870 - BARD GASTROSTOMY FEEDING DEVICE

K890870 is the FDA 510(k) clearance for BARD GASTROSTOMY FEEDING DEVICE by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K890870 · C.R. Bard, Inc. · Gastroenterology & Urology device

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Apr 1989

Decision

65d

Days

Class 2

Risk

K890870 is an FDA 510(k) clearance for the BARD GASTROSTOMY FEEDING DEVICE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on April 27, 1989 after a review of 65 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number	K890870 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 21, 1989
Decision Date	April 27, 1989
Days to Decision	65 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

65d faster than avg

Panel avg: 130d · This submission: 65d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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 252

Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K890870.

PEDI-TUBE(R) STYLET

K894857 · Biosearch Medical Products, Inc. · Oct 1989

KENDALL CURITY STOMACH TUBES

K892439 · The Kendal Co. · Jun 1989

PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE

K891109 · Concept, Inc. · May 1989

BARD MOSS(R) GASTROSTOMY TUBE

K890871 · C.R. Bard, Inc. · Apr 1989

FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT

K884275 · Abbott Laboratories · Dec 1988

NH PEDIATRIC REPLACEMENT GASTROSTOMY KIT

K884309 · Biosearch Medical Products, Inc. · Dec 1988

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K890870

C.R. Bard, Inc.

Billerica, MA · US

ERNEST MANFREDO

Regulatory profile

646 submissions 610 cleared

94% clearance rate · Active in Gastroenterology & Urology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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